FDA Adverse Event Injury Summary report: N

DUROM US ACETABULAR COMPONENT 52/46 L

MDR report key: 1842776 · Received September 10, 2010

Report

Report Number: 9613350-2010-00430
Event Type: Injury
Date Received: September 10, 2010
Date of Event: July 22, 2010
Report Date: August 17, 2010
Manufacturer: ZIMMER GMBH
Product Code: KWA
Removal / Correction Number: 9613350-07/15/2008-001
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

INFO WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER INC., WHICH MARKETS THE DEVICES IN THE U.S. THE MFR 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 INFO PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THE REVISION SURGERY IS RELATED TO THE ISSUE FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN 07/2008. SHOULD ADDITIONAL INFO BECOME AVAILABLE AND / OR THE DEVICE(S) BE RETURNED FOR EVAL 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 PT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. POST OP, PT REPORTS PAIN BEGINNING APPROX 9 MONTHS AGO. PT HAS NOT BEEN REVISED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	DUROM US ACETABULAR COMPONENT 52/46 L	DUROM ACETABULAR COMPONENT AND METASUL	KWA	ZIMMER GMBH	NA	2346480

Patients

Seq	Age	Sex	Outcome	Treatment
1	58 YR		Other