FDA Adverse Event Injury Summary report: N

ZIMMER M/L TAPER MODULAR FEMORAL STEM

MDR report key: 1871079 · Received October 12, 2010

Report

Report Number: 1822565-2010-00885
Event Type: Injury
Date Received: October 12, 2010
Date of Event: August 31, 2010
Report Date: September 7, 2010
Manufacturer: ZIMMER INC.
Product Code: JDI
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

EVAL SUMMARY: NO X-RAYS, SURGICAL REPORT MEDICAL HISTORY OF THE PT, PT'S ACTIVITY LEVEL AND WEIGHT HAS BEEN PROVIDED. IT IS ALSO NOT KNOWN WHETHER PROPER SURGICAL TECHNIQUE AND APPROPRIATE INSTRUMENTS WERE USED IN THE PRIMARY SURGERY OR NOT. STEM LOOSENING MAY BE CAUSED BY: LACK OF PROXIMAL BONY INGROWTH. HIGH ACTIVITY LEVEL OF THE PT. IMPROPER SURGICAL TECHNIQUE. WEAR PARTICLES GENERATED FROM THE MATING BEARING SURFACES. OSTEOLYSIS. PREVIOUS MEDICAL CONDITION OF THE PT. INADEQUATE INSTRUMENTATION HARBOURS THE RISK IF CANCELLOUS BONE IS LOST DUE TO GENEROUS RASPING/REAMING. THIS IS NOT AN EXHAUSTIVE LIST. HOWEVER, NO DEFINITE CAUSE ANALYSIS IS POSSIBLE BASED ON 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 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 FOR A LOOSE STEM THAT HAD SUBSIDED AND CAUSED THE PT PAIN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ZIMMER M/L TAPER MODULAR FEMORAL STEM	HIP PROSTHESIS	JDI	ZIMMER INC.		61068331

Patients

Seq	Age	Sex	Outcome	Treatment
1	85 YR		Required Intervention