Catalog Number 999805158 |
Device Problems
Loss of Osseointegration (2408); Appropriate Term/Code Not Available (3191)
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Patient Problems
Pain (1994); Tissue Damage (2104); Inadequate Osseointegration (2646)
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Event Date 11/07/2017 |
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.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.Complete product detail has not been received at this time.If further information is received a follow-up medwatch will be filed as appropriate.Udi: unavailable.
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Event Description
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Asr revision, asr xl.Reason(s) for revision: pain, component loosening, elevated metal ions(co-cr) doi: (b)(6) 2008; dor: (b)(6) 2017; unknown affected side.
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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.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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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.
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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-(b)(4).Ongoing post market surveillance is conducted per our procedures for this product.Addendum added 22-august-19.Following receipt of additional information, the complaint was re-opened.A review of the additional information identified no additional investigational inputs requiring further investigation.Therefore, no changes are required to the previous investigation conclusions.Corrected: ___________________________________ device history lot = > null.Device history batch = > null.Device history review = > null.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: 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.Addendum added (b)(6) 2019.Following receipt of additional information, the complaint was re-opened.A review of the additional information identified no additional investigational inputs requiring further investigation.Therefore, no changes are required to the previous investigation conclusions.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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