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Two safety alerts issued, lots recalled for three orthopaedic devices
Two knee implants received safety alerts, and Alphatec announced a voluntary recall of a cervical cage.
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Arthroplasty Watch recently distributed information about a Field Safety Notice and voluntary recall for the cervical PEEK cage Samarys by Scient’x, as well as two safety notices for knee prosthesis components — the ACS fixed-bearing cementless porous-coated tibial component by Oceania Orthopaedics and the Scorpio Series 7000 cementless beaded tibial component by Stryker.
The voluntary recall for the Samarys cage is due to the possibility of missing, improperly secured and/or incorrectly positioned gold wire markers in devices manufactured between April 2014 and November 2015, according to a Field Safety Notice (FSN) from Alphatec, parent company of Scient’x. Users are being asked to discontinue using these specific devices. The National Competent Authorities have been notified of this recall. Alphatec noted the recall is voluntary, and no adverse events or incidents have been reported.
Improper wire placement
The devices that are missing the gold wire markers may cause positioning errors during cage insertion at the treated site, which may lead to neurological injury. Also, incorrectly placed gold wire markers may protrude 1 mm to 2 mm inside or outside of the cages and may cause inflammation of the surrounding tissue, the company noted in its FSN.
Oceania Orthopaedics released a safety notice for its ACS fixed-bearing cementless porous-coated tibial component due to higher-than-expected revision rates, according to a safety update from the Australia Government Department of Health Therapeutic Goods Administration that was dated 18 January.
The noticed highlighted that when a tibia-first technique is used with the implant, and the knee is not balanced first, then misalignment of the femoral component is possible when referencing the resected tibia for femoral rotation. In addition, Oceania Orthopaedics found the cementless implant was used in cases in which a cemented implant would have provided better outcomes, so patient selection and intraoperative assessment of bone quality and stability is therefore key to a successful knee replacement surgery, according to the safety notice. Oceania has created a center to train surgeons who are considering the use of cementless implants and urges any new, first-time users of the ACS fixed-bearing cementless porous-coated tibial component to complete the training before they use this implant.
Beaded tibial components investigated
Stryker released a safety alert for its Scorpio Series 7000 cementless beaded tibial components for higher-than-expected revision rates, according to the same Australia Government Department of Health Therapeutic Goods Administration update.
Stryker conducted an investigation of the problem. It found the 7125 cementless tibial component may be adversely affected by inadequate host bone quality in a proportion of cases, but the company noted in the update that the higher revision rates for the 7145 series implants is not device-related. Furthermore, the 7515 series is performing as expected, according to Stryker’s finding. The safety alert noted patient selection and preoperative evaluation are critical for successful outcomes in cementless knee arthroplasty.
- References:
- Australian Government. Department of Health Therapeutic Goods Administration. Medical Devices Safety Update, Volume 4, Number 1, January 2016. Available at: www.tga.gov.au/publication-issue/medical-devices-safety-update-volume-4-number-1-january-2016. Accessed: Feb. 1, 2016.
- Scient’x. Alphatec Spine. Field Safety Notice FSCA – Lots Recall. Available at: www.hsa.gov.sg/content/dam/HSA/HPRG/Medical_Devices/Updates_and_Safety_reporting/Field_Safety_Corrective_Action/FSN/2015/December/HSA%206004101-198-15-01_33%20FSN.pdf. Accessed: Feb. 1, 2016.