Catalog Number 999890251 |
Device Problems
Device Dislodged or Dislocated (2923); Naturally Worn (2988)
|
Patient Problems
Adhesion(s) (1695); Joint Dislocation (2374); No Code Available (3191)
|
Event Date 08/22/2007 |
Event Type
Injury
|
Manufacturer Narrative
|
Product complaint # (b)(4).Initial reporter occupation: lawyer.(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
|
Ppf and medical records received.Ppf has new allegations reported.After review of medical records, the patient was revised due to dislocated right hip.Operative notes reported, the gluteus maximus fibers were very adherent to the underlying abductors and there was a chronic nonunion of the greater trochanter.The leg was short by about 2.5 inches due to chronic dislocation.Doi: (b)(6) 2007 - dor: (b)(6) 2007 (right hip).Please see (b)(4) for the first revision.
|
|
Event Description
|
After review of medical records, revision note reported scar and large metal on metal bearing hip. .
|
|
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. .
|
|
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: this hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.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 will be filed as appropriate.
|
|
Search Alerts/Recalls
|