Model Number 1365-05-000 |
Device Problems
Material Disintegration (1177); Naturally Worn (2988)
|
Patient Problems
Ossification (1428); Cyst(s) (1800); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Synovitis (2094); Tissue Damage (2104); Test Result (2695); No Code Available (3191)
|
Event Date 11/20/2013 |
Event Type
Injury
|
Manufacturer Narrative
|
Product complaint: (b)(4).Investigation summary :no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
Litigation alleges metal wear, metallosis and elevated metal ions.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).
|
|
Event Description
|
After review of medical records, it was indicated that the patient developed pain and elevated cobalt chromium blood level.Operative notes reported that there were pseudocyst, synovitis and a large osteophyte.Which was about half the size of a golf ball.
|
|
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.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.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, a follow-up medwatch will be filed as appropriate.
|
|
Search Alerts/Recalls
|