Catalog Number UNK HIP ACETABULAR LINER |
Device Problems
Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Cyst(s) (1800); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Synovitis (2094); Osteolysis (2377); No Code Available (3191)
|
Event Date 03/27/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
Medical record received.Patient experienced pain.After review of medical record, patient was revised to address right total hip arthroplasty mechanical failure.Favor wear induced synovitis was also stated as clinical findings and aseptic bursitis.Revision notes stated that the osteolytic lesion within the trochanter was easily identifiable as extensive amount of loss of bone in the area.Metallosis was noted and removed all the non viable gray and black tissue from the lining of the joint.The cyst was decompressed which involved of 50 cc of gray materials.Cup and head were removed.Implanted products were not known if depuy products.Doi: unknown.Dor: (b)(6) 2019; (right hip).
|
|
Manufacturer Narrative
|
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # : (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
Medical records indicate that the explanted liner was polyethylene.Corrected (device code for wear).
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.
|
|
Search Alerts/Recalls
|