ZIMMER M/L TAPER HIP MODULAR FEMORAL STEM

Report

Report Number: 1822565-2010-01242
Event Type: Injury
Date Received: December 1, 2010
Date of Event: September 17, 2010
Report Date: November 4, 2010
Manufacturer: ZIMMER, INC.
Product Code: LPH
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

EVAL SUMMARY: THE STERILIZATION PROCESS FOR THIS DEVICE WAS VALIDATED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL (SAL) OF 1.0 X 10(-6) OR BETTER. THE MANUFACTURING LOT SPECIFIED IN THIS COMPLAINT WAS PROCESSED ACCORDING TO THE VALIDATED STERILIZATION PROCESS PARAMETERS AND MET ALL THE ACCEPTANCE CRITERIA FOR STERILITY RELEASE. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE SPECIFIED DEVICE CAUSED OR CONTRIBUTED TO ANY PT INFECTION. EVAL: 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.

Description of Event or Problem · 1

IT IS REPORTED THAT THE PT WAS REVISED DUE TO INFECTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ZIMMER M/L TAPER HIP MODULAR FEMORAL STEM	HIP PROSTHESIS	LPH	ZIMMER, INC.		60880183

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR		Required Intervention	KINECTIV MODULAR NECK\| POLYETHYLENE LINER: CATALOG #00875101136\| LOT #61491732\| LOT #61555332 - MANUFACTURED BY ZIMMER (B)(4)\| LOT #61553954\| CONTINUUM TRILOGY ALLOFIT HIGHLY CROSSLINKED\| VERSYS FEMORAL HEAD: CATALOG #00801803602\| CATALOG #00784803301\| LOT #61540993\| CONTINUUM SHELL: CATALOG #00875705401