Catalog Number 999890147 |
Device Problems
Malposition of Device (2616); Insufficient Information (3190)
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Patient Problems
Host-Tissue Reaction (1297); Pain (1994); Tissue Damage (2104); Not Applicable (3189)
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Event Date 09/09/2007 |
Event Type
Injury
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Event Description
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Asr revision; asr xl; right; reason(s) for revision: alval / soft tissue reaction.
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Manufacturer Narrative
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Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.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.
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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.Depuy still considers this case closed to capa.
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Event Description
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Asr revision.Asr xl.Right.Reason(s) for revision: alval / soft tissue reaction.(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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Event Description
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Asr revision, asr xl, right.Reason(s) for revision: alval / soft tissue reaction.Update received: 2nd july 2014 - amended revision date: (b)(6) 2007, attached scf, added further hospitals: (b)(6), added surgeon: (b)(6) and added further reason(s) for revision: component malalignment and pain.Update ad 21 jun 2018: (b)(4) has been re-opened under (b)(4) because of a new alert received.Update ad 03 may 2018: (b)(4) has been re-opened under (b)(4) because of a new alert received.There are no new or additional information indicated on this update.Dor was already corrected from (b)(6) 2007 from scf previously.Doi: (b)(6) 2005; dor: (b)(6) 2007; right hip.
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Search Alerts/Recalls
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