FDA Adverse Event Injury Summary report: N

DUROM US ACETABULAR COMPONENT 54/48 N

MDR report key: 2171087 · Received July 8, 2011

Report

Report Number: 9613350-2011-00457
Event Type: Injury
Date Received: July 8, 2011
Date of Event: February 17, 2009
Report Date: June 22, 2011
Manufacturer: ZIMMER GMBH
Product Code: KWA
Removal / Correction Number: 9613350-07/15/2008-001C
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

INFORMATION WAS FORWARDED FROM (B)(6), WHICH MARKETS THE DEVICES IN THE U.S. THE MANUFACTURER DID NOT RECEIVE EXPLANTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED 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, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THE REVISION SURGERY IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN (B)(4) 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 CLOSED. (B)(4).

Description of Event or Problem · 1

IT IS REPORTED THAT THE PATIENT UNDERWENT TOTAL LEFT ARTHROPLASTY ON (B)(6) 2007. PATIENT EXPERIENCED PAIN AND REVISION WAS DONE ON (B)(6) 2009, NOTED THAT CUP WAS LOOSENED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	DUROM US ACETABULAR COMPONENT 54/48 N	DUROM ACETABULAR COMPONENT AND METASUL	KWA	ZIMMER GMBH		2338967

Patients

Seq	Age	Sex	Outcome	Treatment
1	64 YR		Hospitalization