FDA Adverse Event Other Summary report: N

DUROM ACETABULAR COMPONENT

MDR report key: 4643190 · Received March 20, 2015

Report

Report Number: 9613350-2015-00341
Event Type: Other
Date Received: March 20, 2015
Date of Event: March 3, 2015
Report Date: March 3, 2015
Manufacturer: ZIMMER GMBH
Product Code: KWA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE MFR 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. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. SHOULD ADD'L INFO BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVAL AND AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION WAS RECEIVED ON JANUARY 19, 2016: THE DEVICE REPORTED IN THIS INCIDENT WAS NOT MANUFACTURED BY ZIMMER (B)(4). THE PRODUCT WAS MANUFACTURED BY ZIMMER INC., (B)(4). ZIMMER (B)(4) WILL INVALIDATE THIS CASE. PLEASE ALSO INVALIDATE THIS CASE FROM YOUR SYSTEM. (B)(4).

Description of Event or Problem · 1

A PRODUCT LIABILITY CLAIM WAS RAISED. IT WAS REPORTED THAT THE PT WAS IMPLANTED A DUROM ACETABULAR COMPONENT ON THE RIGHT SIDE ON (B)(6) 2008. CURRENTLY THE PT IS BEING MONITORED DUE TO PAIN. THIS IS A BILATERAL CLAIM. LEFT SIDE COMPLAINT: (B)(4).

Description of Event or Problem · 1

IT HAS NOW BEEN REPORTED, THAT A TM MODULAR CUP 58MM SOLID WAS IMPLANTED ON (B)(6) 2008. THIS DEVICE WAS MANUFACTURED BY ZIMMER INC., (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
191802	DUROM ACETABULAR COMPONENT	DUROM ACTEABULAR COMPONENT AND METASUL	KWA	ZIMMER GMBH

Patients

Seq	Age	Sex	Outcome	Treatment
1	61 YR		Other