Catalog Number 999890243 |
Device Problems
Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Distress (2329); Discomfort (2330); Deformity/ Disfigurement (2360); Osteolysis (2377); Metal Related Pathology (4530); Swelling/ Edema (4577)
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Event Date 11/16/2022 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).E3 initial reporter occupation: lawyer.D4: the device catalog number is unknown.Therefore, udi is unavailable.Investigation summary: no device associated with this report was received for examination.The asr platform was voluntarily recalled from the market in (b)(6) 2010, and the asr product codes are now considered inactive.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: device history reviews for asr platform have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, depuy synthes, 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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Event Description
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The patient suffered severe pain and discomfort, increased metal levels in her blood including cobalt and chromium, permanent injuries, emotional distress, disability, and disfigurement as a result of the implantation with her right asr hip implant.Doi: (b)(3) 2009.Dor:(b)(3) 2022.Right 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.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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On (b)(6) 2022, the surgeon discovered there was a large fluid-filled capsular extension to the area.The capsule was opened and was noted to have a large amount of cloudy yellow-white fluid with some debris within it.The pseudocapsule was noted to be inflamed.There was metal debris around the neck of the stem.There was osteolysis tracked into the canal but about 15mm.There was osteolysis noted by the calcar.There were areas behind the cup that had some metal debris.
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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.The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: device history reviews for asr platform have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.
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Search Alerts/Recalls
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