MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 01/01/2003

Event Type  malfunction  

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, "comparison of complications after transtrochanteric and posterolateral approaches for primary total hip arthroplasty" written by mark f.Schinsky, md, ohannes a.Nercessian, md, raymond r.Arons, drph, and william macaulay, md published by the journal of arthroplasty vol.18 no.4 2003 was reviewed.The article's purpose was to compare the incidence of complications in a consecutive series of primary total hip arthroplasties performed by a single surgeon in matched groups through either the transtrochanteric lateral or the posterolateral approach.Data was compiled from 100 thas performed between december 1987 and september 1990 and 100 thas performed between october 1990 and november 1995.There were 100 in transtrochanteric group and 100 in the posterolateral group.Depuy and non depuy implants were utilized and depuy or non depuy cement was utilized for cemented femoral stems or cemented acetabular components.The article does not provide adequate information to identify which products were associated with the adverse events.Although not identified, it is assumed that complimentary acetabular and bearing components were depuy when depuy stem was utilized.Depuy products: charnley stem utilized in posterolateral group, head, liner, cup.Adverse events: heterotopic ossification (no information regarding interventions).Trochanteric bursitis (no information regarding interventions).Dislocation (no information regarding interventions).Acetabular osteolysis (no information regarding interventions).Leg-length discrepancy (no information regarding interventions).Subsidence of femoral implant (no information regarding interventions).Greater trochanteric fracture (treated by surgical re-attachment).

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.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9629209
• MDR Text Key: 189351202
• Report Number: 1818910-2020-02924
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/14/2020
• Initial Date FDA Received: 01/24/2020
• Supplement Dates Manufacturer Received: 03/09/2020
• Supplement Dates FDA Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1