FDA Adverse Event Injury Summary report: N

UNKNOWN ZIMMER HIP

MDR report key: 1930684 · Received December 14, 2010

Report

Report Number: 1822565-2010-01340
Event Type: Injury
Date Received: December 14, 2010
Date of Event: January 24, 2005
Report Date: November 15, 2010
Manufacturer: ZIMMER, INC.
Product Code: KWY
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

INFO WAS RECEIVED FROM A CUSTOMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: IT IS NOT KNOWN AT THIS TIME IF THE PRODUCTS REMOVED WERE ZIMMER PRODUCTS. THE OP NOTES FROM THE REVISION SURGERY WERE PROVIDED. IT WAS NOTED THAT THE ACETABULAR COMPONENT WAS LOOSE AND HAD MIGRATED PROXIMALLY INSIDE THE ACETABULUM. ADDITIONALLY, THE FEMORAL COMPONENT WAS STABLE. 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 AGE, 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. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. 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 AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, 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 LOOSENING. OSTEOLYSIS IS ALSO REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	UNKNOWN ZIMMER HIP	HIP PROSTHESIS	KWY	ZIMMER, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention