FDA Adverse Event Other Summary report: N

DUROM ACETABULAR COMPONENT

MDR report key: 2823641 · Received October 30, 2012

Report

Report Number: 9613350-2012-01018
Event Type: Other
Date Received: October 30, 2012
Date of Event: October 8, 2012
Report Date: October 8, 2012
Manufacturer: ZIMMER GMBH
Product Code: KWA
Removal / Correction Number: 9613350-07/15/2008-001C
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW, AS THE PATIENT HAS NOT BEEN REVISED TO DATE. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, AS THE PATIENT HAS NOT BEEN REVISED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THIS CASE MIGHT BE RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN JULY 2008. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND / OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

Description of Event or Problem · 1

A PRODUCT LIABILITY CLAIM WAS RAISED. IT WAS REPORTED THAT THE PATIENT RECEIVED A DUROM ACETABULAR CUP ON (B)(6) 2009. IT IS UNKNOWN IF THE PATIENT IS CURRENTLY BEING MONITORED OR IF REVISION SURGERY IS PLANNED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	DUROM ACETABULAR COMPONENT	DUROM US ACETABULAR COMPONENT 50/44 J	KWA	ZIMMER GMBH		2419526

Patients

Seq	Age	Sex	Outcome	Treatment
1	47 YR		Other