Catalog Number 999800752 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cyst(s) (1800); Foreign Body Reaction (1868); Pain (1994); Metal Related Pathology (4530); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/09/2020 |
Event Type
Injury
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Event Description
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Asr litigation record received.Patient alleges elevated metal ion, pain, injury, and suffering.Doi: (b)(6) 2008.Dor: (b)(6) 2020, (right hip).
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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 no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot previous investigations that have included manufacturing record evaluations (mre) since the asr platform was launched have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : previous investigations that have included manufacturing record evaluations (mre) since the asr platform was launched have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.
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Event Description
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Patient was revised to address adverse local tissue response/mom hip articulation.Revision notes stated that there was moderate presence of corrosion product and 8ml brownish colored opaque fluid was aspirated.There was synovial proliferation with mild cystic formation.Doi: (b)(6) 2008.Dor: (b)(6) 2020.(right hip).
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Search Alerts/Recalls
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