Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Muscle/Tendon Damage (4532)
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Event Date 08/16/2022 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent a right knee revision approximately thirteen months post-implantation after the patient's medial collateral ligament was cut during the initial procedure and more conservative intervention had been unsuccessful.
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, associated reports: 0001822565-2022-02586, 0001822565-2022-02587.Concomitant medical products: unknown femoral, unknown tibial insert.Foreign source:(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Manufacturer Narrative
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Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.It was alleged that the issue was due to surgeon error, however without medical records a definitive root cause cannot be identified.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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No further event information available at the time of this report.
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Search Alerts/Recalls
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