Catalog Number 999804550 |
Device Problems
Loose or Intermittent Connection (1371); Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Foreign Body Reaction (1868); Pain (1994); Inadequate Osseointegration (2646); Test Result (2695); No Code Available (3191)
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Event Date 03/23/2012 |
Event Type
Injury
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Manufacturer Narrative
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(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; right hip; reason for revision:alval/soft tissue reaction.Doi: (b)(6) 2009; dor: (b)(6) 2012 (right hip).
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Manufacturer Narrative
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Product complaint # (b)(4).(b)(4) used to capture the patient code surgical intervention.
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Event Description
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Surgeon confirmation form received.Patient experienced pain, metallosis at the trunion, component loosening and elevated metal ion was noted.Corrected implant and revision date.Added patient identifier and laboratory data.
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Manufacturer Narrative
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Product complaint # : (b)(4).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.H6 patient code: no code available (3191) used to capture blood heavy metal increased, medical device removal and surgical intervention patient codes.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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Surgeon confirmation form received.Patient experienced pain, metallosis at the trunion, component loosening and elevated metal ion was noted.Doi: (b)(6) 2008.Dor: (b)(6) 2012.Right hip.
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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.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.Device history lot : null.Device history batch : null.Device history review : null.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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