Catalog Number UNK HIP FEMORAL HEAD |
Device Problems
Device Dislodged or Dislocated (2923); Naturally Worn (2988)
|
Patient Problems
Edema (1820); Foreign Body Reaction (1868); Pain (1994); Joint Dislocation (2374); No Code Available (3191)
|
Event Date 01/20/2012 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
|
|
Event Description
|
The literature article entitled, ""large-diameter modular metal-on-metal total hip arthroplasty"" written by william p.Barrett, md, kirk a.Kindsfater, md, and james p.Lesko published by the journal of arthroplasty vol.27 no.6 2012 accepted by publisher 20 january 2012 was reviewed.The article's purpose is to present the results of 4 clinical trials with modular mom bearing total hip system with special focus on the small subset of revisions attributed to an armed (adverse reaction to metallic debris).The data was compiled from 4 studies of 779 thas and pulled 22 revision cases.All cases had depuy products and each case is captured individually in linked complaints.Depuy products: stem (various and identified individually), pinnacle cup, ultamet metal liner, metal femoral head this complaint captures case #2 (b)(6) male with summit stem and received revision 1.2 years post initial implantation for suspected infection and positive findings of armed.Narrative description provides further detail of presentation of pain and swelling, intraoperative finding of a large necrotic mass involving the periacetabular soft tissue.Head and liner were only exchanged to mop bearings.He was noted to have non-significant metallic debris.He also experienced dislocations presumably due to soft tissue compromise.Further investigation and tests reveal negative findings of infection.
|
|
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.H10 additional narrative: corrected: h6.Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot: null.Device history batch: null.Device history review: null.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.
|
|
Search Alerts/Recalls
|
|