Catalog Number 999890251 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Pocket Erosion (2013)
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Event Date 05/12/2020 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint #: (b)(4).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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Left tha performed in 2008 due to osteoarthritis.Asr implants and depuy summit stem were used.Revision was completed secondary to pain and metalosis.Operative notes stated that there was a slight increase in iron levels.Mri did not show evidence of pseudotumor.Significant inflammation of the capsule and erosion of the bony inferior aspect of the acetabulum was observed.Patient also experienced significant trunnionosis from the cobalt chrome head.Doi: (b)(6) 2008, dor: (b)(6) 2020, left hip.
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Event Description
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Additional information was received indicating that this is an actively litigated asr case.
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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.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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Manufacturer Narrative
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Product complaint #(b)(4).Mfr# 1818910-2022-00265 is being retracted since it was found to be a duplicate of mrf# 1818910-2020-16824.Mfr# 1818910-2020-16824 will be kept for investigation purposes.
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Search Alerts/Recalls
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