Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problems
Foreign Body Reaction (1868); Foreign Body In Patient (2687)
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Event Date 04/03/2023 |
Event Type
Injury
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Event Description
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It was reported during a right knee arthroscopy with acl reconstruction with quadgraft, medial meniscus repair, a metallic remnant from the meniscal repair device was retained in the posterior medial aspect of the knee.Procedure x-ray confirmed the retention.Additional surgery was done to remove the retained object.Attempts have been made and there is no further information at this time.
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Manufacturer Narrative
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(b)(4).H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.H3 other text : location is unknown.
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Manufacturer Narrative
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(b)(4).Reported event was confirmed as visual examination of the provided pictures identified a tip of a juggerstitch inserter has been broken off.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 could not 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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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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