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: 3007963827-2019-00301.Medical products: partial tibial cemented right medial item# 42538000402, lot# 64318523.Foreign source (b)(6).Customer has indicated that the product will be returned to zimmer biomet for investigation.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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This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d10; g4; g7; h1; h2; h3; h6.Visual inspection of the returned articular surface exhibits signs of use (nicks and gouges) and is compressed.The dhr was reviewed and no discrepancies relevant to the reported event were found.The surgical technique states that with the engraved side of the articular surface implant down, slide the posterior edge of the polyethylene component under the posterior lip of the base plate.The compressed feature indicates that the device was not properly inserted.The root cause is attributed to use error and user not following instructions.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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