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

Catalog Number UNK HIP FEMORAL STEM

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003); Unintended Movement (3026); Migration (4003)

Patient Problems Unspecified Infection (1930); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 01/01/2003

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.(b)(4).

Event Description

The literature article entitled, "revision total hip arthroplasty the limits of fully coated stems" written by scott m.Sporer, md, ms and wayne g.Paprosky, md, facs published by clinical orthopaedics and related research (2003) was reviewed.The article's purpose "was to evaluate the results of 9-inch calcar and 10-inch fully porous coated stems, impaction bone grafting, and modular tapered stems used during revision femoral surgery for paprosky type iii and type iv femoral defects." data was compiled from 71 patients receiving femoral revision between 1991 and 2001 with follow up range of 2-11 years.It is noted that depuy stems and non-depuy stems were utilized in the revision procedures.The article does not identify which specific products were associated with the adverse events.The article does not provide adequate information to determine accurate quantities.The article focuses on the stems and does not discuss the head or acetabular components.Depuy products utilized: solution stem.Adverse events: infection (treated by re-revision), stem loosening (treated by re-revision), stem subsidence (treated by re-revision).No further details on interventions.

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.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 46581-0988 ; 6103142063
• MDR Report Key: 9458597
• MDR Text Key: 185110056
• Report Number: 1818910-2019-122745
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention