Model Number N/A |
Device Problem
Unstable (1667)
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Patient Problems
Failure of Implant (1924); Insufficient Information (4580)
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Event Date 01/19/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10 - medical product: femur trabecular metal posterior stabilized (ps) catalog # 42500206402, lot # 64278458.Unk persona tibial.H3: customer has indicated that the product will not be returned because product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001822565-2024-00002.H3 other text : product location unknown.
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Event Description
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It was reported patient underwent a revision procedure fourteen months post implantation due to instability.Attempts to obtain additional information have been made; however, no more is available at this time.
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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.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause cannot be determined.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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Search Alerts/Recalls
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