This article is more than 5 years old. Information may no longer be current.
Stryker issues lot-specific recall for Exeter Tapered Pin Reamer
The lot numbers listed in Stryker’s field safety notice are GW281208, GW284192, GW288907, GW282586, GW282310, GW298838, GX303720, GX302994, GX301732, GW288908, GW282454 and GW288485.
According to the notice, “Stryker Orthopaedics has received a customer complaint which reported that during a total hip replacement, the surgeon was using the Exeter small tapered pin reamer (0932-0-000 lot #GW281208) when the device fractured approximately 3 inches from the tip.”
In the notice, Stryker listed potential hazards of the two tapered pin reamer devices, which include detachment of the tip of the reamer from the instrument, corrosion-related excessive metal ions and displacement from MRI. The following potential patient harms could occur as a result:
- complications linked with a delay in surgery of 15 minutes or less;
- complications associated with a surgical delay of 31 minutes to 60 minutes;
- complications associated with a delay in surgery of more than 60 minutes;
- wound healing that is prolonged;
- an inflammatory response to inert particulates;
- local necrosis; and
- pain.
To mitigate instances of exposure to an MRI field that has the potential to cause movement or translation of implanted stainless steel within the patient’s femur, the notice refers patients and surgeons to the precautions and warnings listed in the Instructions for Use for Total Hip Joint Replacement Prostheses for Cementless and Cemented Applications included in the Exeter hip stem implant package.
Reference:
www.hpra.ie/docs/default-source/field-safety-notices/sept-2015/v25661_fsn.pdf?sfvrsn=2.