Catalog Number 999890251 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 11/09/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Patient code: no code available (3191) used to capture the surgical intervention and medical device removal.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that the patient has a 58 mm asr cup, 1-1 spacer, and 51 asr head.Patient has a pain and elevated metal ion levels.Surgeon removed cup, head and spacer.She left the stem in patient implanted in 64mm multi hole gription cup, 4/10 40mm liner and a 8.5mm ts ceramic 40mm head.Doi: (b)(6) 2008 - dor: (b)(6) 2021 (left hip).
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed andthe investigation will be re-opened as necessary.Device history lot device history reviews for asr platform have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.
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Search Alerts/Recalls
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