Model Number N/A |
Device Problems
Loose or Intermittent Connection (1371); Migration (4003)
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Patient Problem
Joint Dislocation (2374)
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Event Date 11/29/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source, foreign - event occurred in (b)(6).Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation is complete, a supplemental mdr will be submitted.Concomitant medical products: medical product: unk oxford bearing catalog #: not reported lot #: not reported medical product: unk oxford tibial component catalog #: not reported lot #: not reported.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
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Event Description
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It was reported that a patient underwent an initial knee replacement procedure.Subsequently, a revision procedure due to aseptic loosening and dislocation of the femoral implant was performed.
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Event Description
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It was reported that a patient underwent an initial knee replacement procedure.Subsequently, a revision procedure due to aseptic loosening and dislocation of the femoral implant was performed.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Concomitant medical products: medical product: oxf anat brg lt md size 5 pma catalog #: 159549 lot #: 2361707.Medical product: oxf uni tib tray sz d lm pma catalog #: 154724 lot #: 2330295.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
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Event Description
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It was reported that a patient underwent an initial knee replacement procedure.Subsequently, a revision procedure due to aseptic loosening and dislocation of the femoral implant was performed.
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Search Alerts/Recalls
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