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

Catalog Number UNK HIP FEMORAL STEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Thrombosis (2100); Post Operative Wound Infection (2446); No Code Available (3191)

Event Date 08/22/2003

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, "primary total hip arthroplasty using a modular proximally coated prosthesis in patients older than 70" written by scott m.Sporer, md, raymond j.Obar, rn, and philip m.Bernini, md published by the journal of arthroplasty vol.19 no.2 2004 accepted by publisher 22 august 2003 was reviewed.The article's purpose was to report on clinical and radiographic results on primary thas with modular proximally coated femoral components.Data was compiled from primary thas between december 1993 and january 1998 of 122 patients (135 thas) over the age of 70 years old.All implants were depuy products.The article provides generalized results but also identifies 2 patients in radiographic results which are captured individually in linked complaints.Depuy products utilized: srom stem, duraloc or ztt cups, cocr or ceramic heads, poly liners.This complaint captures the generalized findings of wound infection (treated by repeated irrigation and debridement), intraoperative non-displaced vertical fractures of metaphysis during sleeve insertion (no change in post operative protocol and fractures healed uneventfully without surgical intervention), dvt (treated with prolonged anti-coagulation), radiographic findings of osteolysis in femur and acetabulum (no interventions provided - article associates osteolysis with poly wear), radiographic of heterotopic ossification (no indication of negative impact to patient and no indication of intervention).The article does not provide adequate information to determine accurate quantities for the generalized adverse events.

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 device history record (dhr) review, was not possible because the required lot number was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch, a follow-up 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, PA 46581-0988 ; 6107428552
• MDR Report Key: 9411434
• MDR Text Key: 185635493
• Report Number: 1818910-2019-120222
• Device Sequence Number: 1
• Product Code: KXA
• 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: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 01/03/2020
• 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