Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Failure of Implant (1924); Insufficient Information (4580)
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Event Date 12/06/2022 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent revision surgery due to unknown reasons, approximately eight (8) months after initial surgery.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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Manufacturer Narrative
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(b)(4).Concomitant medical products: product id: oxf twin-peg cmntd fem sm pma, item#: 161468, lot#: 947260; product id: oxf uni tib tray sz aa lm pma, item#: 159531, lot#: 297320.Multiple mdr reports were filed for this event: 3002806535-2022-00515 and 3002806535-2022-00516.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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Event Description
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It was reported that the patient underwent revision surgery due to tibial subsidence approximately eight (8) months after initial surgery.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Devices are used for treatment.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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Search Alerts/Recalls
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