BIOMET UK LTD. ARCOS DISTAL SCREW TI 5X40MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number 166068 |
Device Problem
Fracture (1260)
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Patient Problems
Failure of Implant (1924); Foreign Body In Patient (2687)
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Event Date 03/08/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10 - associated medical devices: unknown stem; item# unknown; lot# unknown.G2 - foreign: united kingdom.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 the patient experienced a fracture of one of the two upper distal screws.The stem remained stable, and the patient remained asymptomatic.This event is related to a malfunction which is considered a serious injury.However, no further outcome was reported.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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(b)(4).Complaint further investigated following receipt of the item number.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records could not be performed due to missing lot number.With the available information, 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 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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