DEPUY ORTHOPAEDICS, INC. - 1818910 SUMMIT POR TAPER SZ2 HI OFF; HIP FEMORAL STEM/SLEEVE
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Catalog Number 157011080 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Host-Tissue Reaction (1297)
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Event Date 12/15/2015 |
Event Type
Injury
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Manufacturer Narrative
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions.(b)(4).Depuy considers the investigation closed at this time.Should the product and/or additional information be received, the investigation will be re-opened.(b)(4).
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Event Description
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Asr revision, asr xl - right hip, reason(s) for revision: noise, alval / soft tissue reaction, metal ions.
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Manufacturer Narrative
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Upon further review, it was noticed that this device is not contributing to the issue; therefore; this report is being rejected.
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Search Alerts/Recalls
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