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Zimmer Biomet issues voluntary field safety corrective action involving cementless uni knee system
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Biomet UK Ltd. initiated a voluntary field safety corrective action involving the cementless Oxford partial knee unicompartamental knee replacement system, according to a recent notice from Zimmer Biomet.
According to the notice, there has been a trend in tibial plateau fractures involving specific components of the system. An analysis of the complaint rates showed a 0.12% world-wide occurrence of patients who experienced tibial plateau fractures. The trend in tibial plateau fractures has involved procedures that used the Oxford unicompartmental cementless tibial trays LM size AA through RM size F. The analysis of the complaints showed that if a tibia fracture occurred, the treating orthopedic consultant has identified it within 25 days of the primary surgery. According to the notice, 17% of those fractures have been conservatively treated.
The tibial trays reportedly were manufactured based on pre-defined specifications. An investigation into the cause of these fractures has demonstrated the importance of following certain steps in the applicable surgical technique to reduce the risk of tibial plateau fractures.
“By means of this notice, we would like to emphasize the importance of adhering to the applicable surgical technique and the appropriate sections in the ‘Instruction for Use’ packaged with the products,” the notice read.
Reference:
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