Catalog Number 999804652 |
Device Problem
Noise, Audible (3273)
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Patient Problems
Host-Tissue Reaction (1297); Tissue Damage (2104); Not Applicable (3189)
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Event Date 05/13/2016 |
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.
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Event Description
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Patient underwent a revision to address alval/soft tissue reaction and noise.
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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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Event Description
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Complaint description: asr revision asr resurfacing right reason(s) for revision: alval / soft tissue reaction and noise doi: (b)(6)2005; dor: (b)(6)2016; right hip update mar 23, 2018 additional information received from (b)(6), as per review of the new information there is no update to the pc.
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Search Alerts/Recalls
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