Catalog Number 999804550 |
Device Problems
Loss of Osseointegration (2408); Noise, Audible (3273)
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Patient Problems
Foreign Body Reaction (1868); Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)
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Event Date 11/07/2019 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).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.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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Asr revision.Asr xl.Left hip.Reason for revision: component loosening.Doi: (b)(6) 2008; dor: (b)(6) 2019: left hip.
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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) was 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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The patient was revised due to pain, noise and alval.Doi: (b)(6) 200 dor: (b)(6) 2019 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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