Model Number N/A |
Device Problems
Difficult to Insert (1316); Dent in Material (2526)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/22/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Concomitant medical products: unknown - unknown tibial component - unknown.G2 : foreign country : singapore.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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 an initial surgery, the articular surface would not sit well with the tibial tray.After the implant was removed, it was noted that there was a dent at the edge of the device.The surgical technique was utilized.There was no surgical delay.Attempts have been made and no further information has been provided.
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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; d2; d9; g1; g3; g6; h1; h2; h3; h6.Visual inspection of the returned device found the distal surface to exhibit damage and the locking features are flared.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were not provided.A definitive root cause cannot be determined.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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Event Description
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No further event information available at the time of this report.
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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; d2; d10; g1; g3; g6; h1; h2; h6 d10: 42532007102 - tibia cemented 5 degree stemmed right size e - 65577894 the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Search Alerts/Recalls
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