Model Number N/A |
Device Problems
Positioning Failure (1158); Difficult to Insert (1316)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/27/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001825034-2019-04750.Concomitant medical products partial articular surface right medial, item# 42528200409, lot# 63887348.Report source - (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that, during a unicompartmental knee arthroplasty procedure, an articular surface would not seat to the tibial tray.The surgeon removed the articular surface and tried to insert it multiple times.Although the articular surfaces seemed to mate with the tibial tray, there was concern that the surface was damaged and a backup articular surface was used to complete the procedure.There is no additional information at this time.
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Manufacturer Narrative
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Upon reassessment of the reported event, it was determined to not be reportable as this device was not involved in the event.The initial report was submitted in error and should be voided.
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Event Description
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Upon reassessment of the reported event, it was determined to not be reportable as this device was not involved in the event.The initial report was submitted in error and should be voided.
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Search Alerts/Recalls
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