FDA Adverse Event Other Summary report: N

DE PUY

MDR report key: 21111 · Received February 9, 1994

Report

Report Number
21111
Event Type
Other
Date Received
February 9, 1994
Date of Event
November 2, 1993
Report Date
December 26, 1993
Manufacturer
DE PUY, INC.
Product Code
JDO
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
MA, US
Reporter Occupation
INVALID DATA

Narratives

Description of Event or Problem · 1

IMPLANTATION PERFORMED 9/21/93 DUE TO SEVERE DEGENERATIVE CHANGES & PAIN IN RIGHT HIP. WOUND HEMATOMA EVAUCATED 1 WK POST THR. DISCHARGED FOR APPROXIMATELY 10 DAYS, RETURNEING WITH FEBER OF 100.8 & RIGHT THIGH PAIN. IMPLANT WAS SURGICALLY REMOVED & REPLACED ON 11/2/93.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 DE PUY Implant TOTAL HIP PROSTHETIC JDO DE PUY, INC. SEE ATTACHED 3 RD PAGE

Patients

Seq Age Sex Outcome Treatment
1 74 * Other