Catalog Number UNK HIP FEMORAL SLEEVE ASR |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Foreign Body Reaction (1868); Pain (1994); Distress (2329); Discomfort (2330); Osteolysis (2377); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 02/10/2020 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter occupation: lawyer.(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.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 litigation records received.Litigation alleges elevated levels of cobalt and chromium resulting to painful hip, discomfort, suffering, emotional distress, mental anguish and permanent injuries.Plaintiff is seeking compensation for all the damages.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 report, a follow-up report will be filed as appropriate.
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Event Description
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After review of medical records patient was revised was due to failed right hip arthroplasty metal on metal and elevated metal ion levels.Operatives notes indicated an indentation of the scar proximally which was unsightly and performed scar revision.The scar was noted to be adherent to the subcutaneous layer ang tethering to the deep tissues.Fluid from the hip aspirated was cloudy and noted as evidence of metallosis with gray color staining to the soft tissues and chalky gray substance within the asr head and around the acetabular component.Acetabular component was noted to be retroverted substantially beyond neutral position, some acetabular osteolytic defects.The trunnion had a metallic debris distal to the trunnion surface itself.There was a contained area of osteolysis within the anterior aspect of the greater trochanter.The femoral component showed about 5 degrees of anteversion.Doi: (b)(6) 2008 dor: (b)(6) 2020 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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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 andthe 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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Search Alerts/Recalls
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