Catalog Number UNK HIP ACETABULAR CUP |
Device Problem
Fracture (1260)
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Patient Problems
Adhesion(s) (1695); Calcium Deposits/Calcification (1758); Cyst(s) (1800); Fall (1848); Fatigue (1849); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Discomfort (2330); Ambulation Difficulties (2544); Unspecified Musculoskeletal problem (4535); Solid Tumour (4552); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter: patient initiated litigation.(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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Patient initiated complaint received.It was reported that the patient had a depuy hip replacement and have been using a cane when walking for some time now.It is not known if the patient underwent a revision surgery.However, mri scan showed a 12.4 centimeters mass.Mri from (b)(6) 2018 indicated a adverse tissue reaction/pseudotumor in the left hip.Medical records received.After review of medical records patient was revised to addressed loose and worn out total left hip replacement.Attention was then turned to the capsule where the scar tissue within the hip joint was excised entirely remove all polyethylene, synovitis and debris.The acetabulum was noted to be worn and cracked at the superior portion and also the acetabular liner worn severely with cracking of its rim.The stem was noted to be grossly loose.Doi: (b)(6) 2006; dor: unk ; (left 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.H6 clinical code: appropriate term / code not available (e2402) is used to capture injury (e20).E3 initial reporter occupation: lawyer.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 : the device associated with this report was not returned to depuy synthes for evaluation.All available x-rays were reviewed, and no evidence of implant fracture, disassociation, or anything indicative of a device nonconformance was found.The reported allegation cannot be confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the investigation was not able to retrieve the required lot code.
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Search Alerts/Recalls
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