Model Number N/A |
Device Problem
Migration (4003)
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Patient Problem
Joint Dislocation (2374)
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Event Date 09/19/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source: (b)(6).Concomitant medical products: medical product: oxf ph3 cementless tib sz d rm catalog #: 154920 lot #: 712254.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00632.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 the patient underwent an initial knee replacement procedure at the nuffield orthopaedic centre.Subsequently, due to the femoral component being too small the patient experienced repeated dislocation of the bearing.Revision of the bearing and tibial component were performed.
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Manufacturer Narrative
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(b)(4).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.The possible cause might be femoral component too small and not balanced, as reported by the clinical department.However, the root cause could not be confirmed as we have not received the product, the product identification numbers or x-rays.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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Event Description
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It was reported that the patient underwent an initial knee replacement procedure.Subsequently, due to the femoral component being too small the patient experienced repeated dislocation of the bearing.Revision of the bearing and tibial component were performed.
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Search Alerts/Recalls
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