Catalog Number 999890141 |
Device Problem
Biocompatibility (2886)
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Patient Problems
Pain (1994); Tissue Damage (2104); Test Result (2695); No Code Available (3191)
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Event Date 01/18/2019 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.No pma/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.(b)(4).
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Event Description
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Asr revision; asr xl; left hip.Reason for revision: pain.Doi: (b)(6) 2006 - dor: (b)(6) 2019 update 06 mar 2019.Revision confirmation form received.It was noted that radiological investigations done by the physician were suggestive of alval and loosening of the acetabular component.Surgeon also notes that the patient has risky levels of metal ions in blood, but no lab results were provided.
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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, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions.Ref.Wwcapa (b)(4) superseded by mdd capa (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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