FDA Adverse Event Injury Summary report: N

GENDER SOLUTIONS PROLONG ARTICULAR SURFACE

MDR report key: 2181088 · Received July 22, 2011

Report

Report Number: 1822565-2011-01701
Event Type: Injury
Date Received: July 22, 2011
Date of Event: June 26, 2011
Report Date: June 24, 2011
Manufacturer: ZIMMER INC
Product Code: JWH
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

EVAL SUMMARY: THE ARTICULAR SURFACE IS A GENDER SOLUTIONS NK FLEX, PROLONG, SIZE 00/0, 13MM (00-5428-020-13). THE MATING DEVICE WAS A NK FLEX SIZE B FEMUR. PER ZIMMER NATURAL KNEE PROFILER, 97-5416-009-00, THIS IS OFF-LABEL USAGE. SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) ARE UNK. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD'L SUBSTANTIVE INFO BE REC'D, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

Description of Event or Problem · 1

IT IS REPORTED THAT THE PT WAS REVISED DUE TO ARTICULAR SURFACE FRACTURING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	GENDER SOLUTIONS PROLONG ARTICULAR SURFACE		JWH	ZIMMER INC		60853867

Patients

Seq	Age	Sex	Outcome	Treatment
1	61 YR		Required Intervention