Catalog Number 999805562 |
Device Problem
Naturally Worn (2988)
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Patient Problems
Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Tissue Damage (2104); Test Result (2695); No Code Available (3191)
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Event Date 02/27/2017 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number.The correction/ removal reporting number listed applies to the corresponding product code sold domestically.Initial reporter occupation: lawyer.(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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Asr revision.Type of hip replacement product: asr xl acetabular system.Hip(s) to be revised: left.Reason(s) for revision: scf alleges pain, alval, soft tissue reaction, focal intra osseous pseudotumor and elevated ch and co metal ions.Mri reported adverse reaction to metal debris.Doi: (b)(6) 2008; dor: (b)(6) 2017.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary = > the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.The investigation regarding the root cause(s) and/or corrective actions was conducted under mdd capa-(b)(4).Ongoing post market surveillance is conducted per our procedures for this product.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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