Catalog Number 999890149 |
Device Problem
Noise, Audible (3273)
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Patient Problems
Host-Tissue Reaction (1297); Pain (1994); Tissue Damage (2104)
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Event Date 01/20/2017 |
Event Type
Injury
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Manufacturer Narrative
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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.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: cup loosening / pain / noise / alval / soft tissue reaction.
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Manufacturer Narrative
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(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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Manufacturer Narrative
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(b)(4).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 (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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Complaint description: asr revision asr xl: right reason(s) for revision: cup loosening / pain / noise / alval / soft tissue reaction.Doi:(b)(6)2009; dor:(b)(6) 2017; right hip.
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Search Alerts/Recalls
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