Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/06/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: associated products: item reference:161469, item name:oxf twin-peg cmntd fem md pma, lot number:441890.Item reference:159575, item name:oxf anat brg rt md size 3 pma, lot number:331530.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2023-00029, 3002806535-2023-00036.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 patient underwent revision of partial knee prosthesis due to unknown reasons, approximately 9 years post-op.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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Cmp-(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, d9, g3, g6, h1, h2, h3, h6, h10.No products were 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.Devices are used for treatment.Medical records were not provided.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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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