FDA Adverse Event Injury Summary report: N

DEPUY PROSTHESIS

MDR report key: 18609 · Received August 2, 1994

Report

Report Number
18609
Event Type
Injury
Date Received
August 2, 1994
Date of Event
March 31, 1994
Report Date
March 31, 1994
Manufacturer
DEPUY
Product Code
JDG
Product Problem
Yes
Report Source
User Facility report
Reporter Location
ME, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

S/P THA POLYETHELYNE FAILURE. PATIENT DIAGNOSED WITH RIGHT HIP PAIN. REVISION THA RT. 3/31/94.(D-6) PRODUCT MODEL # - CUP #1107-56-000 INSERT #1115-22-000 FEMORAL #1041-20-000 PRODUCT LOT # - CUP #896820019 INSERT #870360052 FEMORAL #664780005

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 DEPUY PROSTHESIS Implant CUP INSERT FEMORAL JDG DEPUY SEE #5

Patients

Seq Age Sex Outcome Treatment
1 81 YR Required Intervention