FDA Adverse Event Injury Summary report: N

CONVERGE CLUSTER-HOLE POROUS SHELL

MDR report key: 1913957 · Received November 30, 2010

Report

Report Number: 1822565-2010-01214
Event Type: Injury
Date Received: November 30, 2010
Date of Event: October 8, 2010
Report Date: November 1, 2010
Manufacturer: ZIMMER, INC.
Product Code: KWY
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

INFORMATION WAS REC'D FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: (B)(4) . THE MANUFACTURING LOTS SPECIFIED IN THIS COMPLAINT WERE 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 DEVICES CAUSED OR CONTRIBUTED TO ANY PT INFECTION. EVALUATION CODES: NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO 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 INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE REC'D, 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 INFECTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CONVERGE CLUSTER-HOLE POROUS SHELL	HIP PROSTHESIS	KWY	ZIMMER, INC.		61352136

Patients

Seq	Age	Sex	Outcome	Treatment
1	67 YR		Required Intervention	TOTAL HEAD NEUTRAL NECK :\| CATALOG # 7210-32-000, LOT# 61533610\| CATALOG #437732051, LOT# 61445610\| EPSILON AETABULAR HOODED INSERT: