Catalog Number 999805158 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Host-Tissue Reaction (1297); Pain (1994); Tissue Damage (2104)
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Event Date 09/01/2016 |
Event Type
Injury
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Manufacturer Narrative
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(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, asr xl acetabular system - right hip, reason(s) for revision: pain and alval.Doi; (b)(6) 2008; dor; (b)(6) 2016; right hip.
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Manufacturer Narrative
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(b)(4).
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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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