Catalog Number 999890153 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Foreign Body Reaction (1868); Muscular Rigidity (1968); Pain (1994); Ambulation Difficulties (2544); No Code Available (3191)
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Event Date 04/08/2014 |
Event Type
Injury
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Event Description
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Asr revision.Asr xl.Left.Reason(s) for revision : infection / metallosis / patient is alleging the asr implant reaction has caused chronic lymphocytic leukaemia.No patient demographics are required.Revision date is (b)(6) 2014 (exact date is unknown).
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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.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.Ref.Wwcapa (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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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.Left.Reason(s) for revision: infection / metallosis / patient is alleging the asr implant reaction has caused chronic lymphocytic leukaemia.No patient demographics are required.(b)(4).
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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.Depuy still considers this case closed to capa.
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Event Description
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Asr revision; asr xl; left.Reason(s) for revision: infection / metallosis / patient is alleging the asr implant reaction has caused chronic lymphocytic leukaemia.No patient demographics are required.Update 18 dec - dor confirmed as (b)(6) 2014 as per (b)(4) update.On 04 march 2015 - update - rcvd (b)(4) claim and scf - added surgeons name, reasons for revision: component loosening, pain, amended date of revision to correct date on scf - (b)(6) 2014.Rcvd stem information - this is a non depuy stem.
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Event Description
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Claim letter received.It was reported that was a victim of metallosis and was revised to address pain.Claim letter also reported of walking with a limp, gonalgia and slight diffuse stiffness.There were no medical records and laboratory values provided.
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Search Alerts/Recalls
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