Catalog Number 999890151 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Host-Tissue Reaction (1297); Pain (1994); Joint Swelling (2356); No Code Available (3191)
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Event Date 06/25/2013 |
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 / pain.
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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.(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 / pain.Update - legal letter, added all expiry dates, additional hospital, patient name, gender and date of birth, 5 additional reasons for revision.Taken from legal letter dated 23rd feb 2015.Additional hospital - (b)(6) hospital.Patient name - (b)(6).Gender - male.Date of birth - (b)(6) 1967.Additional reasons for revision : damage to surrounding structure / bone and muscle damage / green fluid (abnormal) / elevated cobalt and chromium metal ion level / effusion/bursitis; a secondary inflammatory response related to metal debris.
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Search Alerts/Recalls
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