Catalog Number 999804956 |
Device Problem
Malposition of Device (2616)
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Patient Problems
Pain (1994); No Code Available (3191)
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Event Date 05/10/2016 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Follow up is being conducted to provide more information for the initial reporter regarding the litigation that was received.Once the legal information is provided, a follow-up medwatch will be processed.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.Initial reporter occupation: lawyer.(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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Event Description
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Complaint description: asr revision to take place on (b)(6) 2016, left, xl, reason(s) for revision: pain, component malalignment.Doi: (b)(6) 2008, dor: (b)(6) 2016, left hip.
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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.The investigation regarding the root cause(s) and/or corrective actions was conducted under mdd capa-001226.Ongoing post market surveillance is conducted per our procedures for this product.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.Corrected: patient ((b)(4)) from device revision or replacement to absence of treatment.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Search Alerts/Recalls
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