Catalog Number UNK HIP FEMORAL HEAD |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Tissue Damage (2104)
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Event Date 11/17/2018 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint: (b)(4).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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Alleged loosening, shielding stress, poor joint support and metallosis.Revision surgery not performed yet.
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Event Description
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Implants have been confirmed as asr products.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: this hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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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Search Alerts/Recalls
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