FDA Adverse Event Other Summary report: N

DUROM HIP GENERIC

MDR report key: 2922227 · Received January 15, 2013

Report

Report Number: 9613350-2013-01258
Event Type: Other
Date Received: January 15, 2013
Date of Event: December 21, 2012
Report Date: December 21, 2012
Manufacturer: ZIMMER GMBH
Product Code: KWY
Removal / Correction Number: 9613350-07/15/2008-001C
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: KY, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. 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 THIS CASE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN JULY 2008 AS REFERENCED ABOVE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICES 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

THE PATIENT, THROUGH COUNSEL, IS PURSUING A PRODUCT LIABILITY CLAIM ARISING OUT OF THE ALLEGED USE OF THE DUROM ACETABULAR COMPONENT. IT WAS REPORTED THAT THE PATIENT RECEIVED A DUROM HIP GENERIC ON (B)(4) 2008 AND EXPERIENCED UNKNOWN SYMPTOMS. IT IS UNKNOWN AT THIS TIME IF THE HIP PRODUCT IS ACTUALLY THE DUROM CUP AND IT IS FURTHER UNKNOWN IF THE PRODUCTS WILL BE RETURNED TO ZIMMER. THE PATIENT IS CURRENTLY BEING MONITORED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
21744	DUROM HIP GENERIC	DUROM HIP GENERIC	KWY	ZIMMER GMBH		UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other