Catalog Number UNK HIP FEMORAL HEAD |
Device Problems
Device Dislodged or Dislocated (2923); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Fatigue (1849); Foreign Body Reaction (1868); Pain (1994); Weakness (2145); Joint Dislocation (2374); Ambulation Difficulties (2544); No Code Available (3191)
|
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.
|
|
Event Description
|
Pinnacle litigation record received.Plaintiff alleges pain, muscle weakness and walking difficulty.Doi: (b)(6) 2013; dor: not reported (left hip).
|
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
Pfs alleges loose cup, fracture component, dislocation, metal wear and metallosis.After review of medical records, there was no revision event for the left hip.
|
|
Manufacturer Narrative
|
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
|
|
Manufacturer Narrative
|
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4) investigation summary: no device associated with this report was received for examination.Review of the x-ray evidence was able to confirm the dislocation event, it can be observed that the femoral head is not properly articulated with the acetabular liner.However, the worn condition cannot be confirmed without a visual examination of the explanted implant.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot = > a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.H10 additional narrative: added: d6a.
|
|
Search Alerts/Recalls
|