FDA Adverse Event Injury Summary report: N

ZIMMER

MDR report key: 110748 · Received August 2, 1997

Report

Report Number
33141-1997-00001
Event Type
Injury
Date Received
August 2, 1997
Date of Event
July 31, 1997
Report Date
August 1, 1997
Manufacturer
ZIMMER, INC.
Product Code
HTG
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
IN, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

PT COMPLAINED OF PAIN. IT WAS FOUND THAT THE PLASTIC HAD SEPARATED FROM THE METAL. THE MG I PATELLA WAS REPLACED WITH A 00-5220-013-00. THE MG I PATELLA WAS A WHITE POROUS IMPLANT. THE HOSPITAL DISCARDED THE DEVICE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ZIMMER Implant MG PATELLA HTG ZIMMER, INC. NA UNK

Patients

Seq Age Sex Outcome Treatment
1 89 YR Required Intervention