NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE

Report

Report Number: 2648920-2013-00053
Event Type: Injury
Date Received: February 21, 2013
Date of Event: January 16, 2013
Report Date: January 22, 2013
Manufacturer: ZIMMER TURPEAUX INDUSTRIAL PARK
Product Code: JWH
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

INFORMATION WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, HEIGHT/WEIGHT, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) ARE UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION 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 PROBLEMS. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A CLICKING SENSATION IN FLEXION AND SOME PAIN WITH ACTIVITY. IT WAS DETERMINED THAT HIS KNEE HAD STRETCHED OUT AND HE REQUIRED A THICKER INSERT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
75134	NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE		JWH	ZIMMER TURPEAUX INDUSTRIAL PARK		61939971

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR		Required Intervention