DUROM US ACETABULAR COMPONENT 52/46 L

Report

Report Number: 9613350-2012-01193
Event Type: Injury
Date Received: December 27, 2012
Date of Event: April 27, 2012
Report Date: December 4, 2012
Manufacturer: ZIMMER GMBH
Product Code: KWA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NV, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. A PRODUCT FAILURE CANNOT BE CONFIRMED. A TIGHT MONITORING IS ONGOING FOR REVISIONS WITH US DUROM CUPS WHERE THE INITIAL IMPLANT DATE OCCURRED AFTER THE RELAUNCH OF THE US DUROM CUP. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME. (B)(4).

Description of Event or Problem · 1

IT HAS BEEN REPORTED THAT THE PATIENT RECEIVED A DUROM US ACETABULAR COMPONENT 52/46 L, LEFT SIDE, ON (B)(6) 2008. ON AN UNKNOWN DATE, "THE PATIENT SUFFERED PAIN AND LIMITED MOBILITY CONTINUOUSLY AFTER THE IMPLANT ALSO CLICKING AND POPPING NOISES WERE HEARD IN HIS HIP." THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2012 DUE TO PAIN, LOOSENING AND HIGH LEVEL OF COCR IN THE BLOOD. IT WAS ALSO REPORTED THAT DURING REVISION SURGERY "SURGEON NOTED THAT, THERE WAS FLUID COLLECTION IN THE HIP, CORROSION OF THE TAPER AND ACETABULAR COMPONENT WAS LOOSE HENCE IT WAS REMOVED EASILY.

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		2346480

Patients

Seq	Age	Sex	Outcome	Treatment
1	69 YR		Hospitalization\| R