FDA Adverse Event Malfunction Summary report: N

NATURAL-HIP SYSTEM COLLARLESS STEM POROUS

MDR report key: 1082074 · Received July 23, 2008

Report

Report Number: 1822565-2008-00438
Event Type: Malfunction
Date Received: July 23, 2008
Date of Event: May 22, 2008
Report Date: June 23, 2008
Manufacturer: ZIMMER, INC.
Product Code: KWY
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

EVALUATION SUMMARY: THE REPORTED COMPLAINT WAS THAT THE STEM FINISHED PROD OF THE BROACH POSITION WHEN FULLY INSERTED. THE STEM WAS IMPLANTED, AND THUS COULD NOT BE RETURNED FOR INVESTIGATION. THE FILMS WERE NOT PROVIDED. THE FINAL BROACH USED IS UNK. POSSIBLE CAUSES OF THE COMPLAINT COULD BE RELATED TO (BUT NOT LIMITED TO) ONE OR MORE OF THE FOLLOWING: INCORRECT FINAL BROACH USED; MAL-ALIGNMENT OF THE BROACH IN THE REAMED CANAL; 30 CANAL NOT REAMED OR BROACHED TO THE APPROPRIATE DEPTH. HOWEVER, THE EXACT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFO. EVALUATION CODES: NO PRODUCT WAS RETURNED. 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 ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.

Description of Event or Problem · 1

IT IS REPORTED THAT DURING SURGERY IN 2008, THE STEM FINISHED PROUD OF THE BROACH POSITION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	NATURAL-HIP SYSTEM COLLARLESS STEM POROUS	HIP PROSTHESIS	KWY	ZIMMER, INC.	NA	60876550

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK