Catalog Number 999800105 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191); Noise, Audible (3273)
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Patient Problems
Foreign Body Reaction (1868); Headache (1880); Pain (1994); Test Result (2695); No Code Available (3191)
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Event Date 09/25/2013 |
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 pain, metallosis, noise and elevated metal ion levels.
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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.Patient code: no code available (3191) is used to capture device revision or replacement.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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Event Description
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Patient had pain at the hip, continuous headache and exhaustion.Doi: (b)(6) 2007 and dor: (b)(6) 2013 (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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Search Alerts/Recalls
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