FDA Adverse Event Injury Summary report: N

GENDER SOLUTIONS NATURAL KNEE ART SURFACE

MDR report key: 2082918 · Received May 3, 2011

Report

Report Number
1822565-2011-01095
Event Type
Injury
Date Received
May 3, 2011
Report Date
April 5, 2011
Manufacturer
ZIMMER INC
Product Code
JWH
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 1

THS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

Description of Event or Problem · 1

IT IS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 GENDER SOLUTIONS NATURAL KNEE ART SURFACE MNH JWH ZIMMER INC 60964471

Patients

Seq Age Sex Outcome Treatment
1 Other GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM GENDER| LOT # 61103144| SOLUTIONS FEMORAL COMPONENT, CATALOG #00541201702| GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM PATELLA| NATURAL-KNEE SYSTEM STEMMED TIBIAL BASEPLATE:| CATALOG # 621201230, LOT # 61168765| COMPONENT: CATALOG #00541800001, LOT # 61086329