Catalog Number 999890243 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cyst(s) (1800); Foreign Body Reaction (1868); Necrosis (1971); Pain (1994); Distress (2329); Discomfort (2330); Deformity/ Disfigurement (2360); Osteolysis (2377); Metal Related Pathology (4530); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 01/25/2022 |
Event Type
Injury
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Event Description
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Litigation complaint received ad 25 may 2022.After review of litigation records, plaintiff alleges severe pain and discomfort, increased metal levels in blood including cobalt and chromium; permanent injuries, emotional distress, disability, disfigurement and economic damages.Doi: (b)(6) 2007.Dor: (b)(6) 2022.Affected side: right hip.
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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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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: 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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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.(health effect - clinical code) previously reported appropriate term / code not available (e2402) used to capture the blood heavy metal increased is now updated to (e1618) for metal related pathology.
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Event Description
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Update ad 24 jun 2022.After review of medical records, it was reported that the patient was revised due to failed metal on metal right tha with elevated metal ions and local alval soft tissue reaction.Operative notes reported that upon incision a turbid fluid was encountered.The vast majority of the pericapsular tissue was necrotic.Upon inspecting the acetabulum, it was noted that there were at least 3 areas that demonstrated erosive cystic changes consistent with alval soft tissue reaction.
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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 : 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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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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Pfs provided product code of the asr component.However, there is no harm and product deficiency provided.After review of the medical records the patient was confirm revised to address elevated metal ions and local alval soft tissue reaction.Operative note reported turbid fluid approx.25-30 ml, necrotic tissue, caseous appearing tissues, erosive cystic changes consistent with the alval soft tissue reaction these were all removed.
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Search Alerts/Recalls
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