Catalog Number UNK HIP FEMORAL HEAD |
Device Problem
Device Dislodged or Dislocated (2923)
|
Patient Problem
Joint Dislocation (2374)
|
Event Date 02/13/2003 |
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 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 will be filed as appropriate.
|
|
Manufacturer Narrative
|
Product complaint # (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, ""dislocation after total hip replacement in relation to metal-on-metal bearing surfaces"" written by m.T.Clarke, p.T.H.Lee, and r.N.Villar published by the journal of bone and joint surgery accepted by publisher 13 february 2003 was reviewed.The article's purpose was to identify the significant difference in the rate of dislocation between patients with cop bearing surfaces compared to mom bearing surfaces.The article focuses on dislocation occurrences and gives no indication of interventions.Data was compiled from 131 cop bearing surfaces and 108 mom bearing surfaces with identified 10 cases of dislocations.Those 10 cases are captured individually in linked complaints with their identified bearing surfaces and acetabular components.All patients were implanted with depuy products and all patients received the same cemented femoral ultima stem." this complaint captures case number 6 of a (b)(6) years old female that experienced a anterior dislocation 6 day(s) post implantation.Acetabular cup was duraloc noted at 47 degree of inclination and bearing surface with cop.
|
|
Search Alerts/Recalls
|