FDA Adverse Event Injury Summary report: N

NCB PERIPROSTHETIC DISTAL FEMUR PLATE, RIG

MDR report key: 3934835 · Received June 20, 2014

Report

Report Number: 9613350-2014-03634
Event Type: Injury
Date Received: June 20, 2014
Date of Event: May 28, 2014
Report Date: May 28, 2014
Manufacturer: ZIMMER GMBH
Product Code: HRS
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE MANUFACTURER DID NOT YET RECEIVE THE DEVICE. IT IS STILL WITHIN THE HOSPITAL, BUT AS MENTIONED BY COMPLAINANT, THE HOSPITAL IS WAITING FOR PATIENT'S "DECLARATION OF AGREEMENT FOR DEVICE INVESTIGATION BY MANUFACTURER." AS SOON AS IT IS RECEIVED, THE HOSPITAL WILL PROVIDE THE DEVICE FOR INVESTIGATION. TWO COPIES OF X-RAYS WERE PROVIDED FOR REVIEW. SURGICAL REPORTS AND OTHER SOURCE DOCUMENTS WERE NOT PROVIDED 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 INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE THAT CHANGES THIS ASSESSMENT, AS AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

Description of Event or Problem · 1

IT IS REPORTED THAT A PATIENT WITH A PERIPROSTHETIC FRACTURE WAS TREATED ON (B)(6)2014 WITH A NCB PERIPROSTHETIC DISTAL FEMUR PLATE, RIGHT, 12 HOLES (EXACT CATALOGUE NUMBER NOT REPORTED) ON THE RIGHT SIDE. IT IS ALSO REPORTED THAT THE PLATE WAS REVISED ON (B)(6) 2014 DUE TO BREAKAGE OF THE PLATE. ACCORDING TO DOCTOR'S EMERGENCY REPORT, THE BREAKAGE OCCURRED WHILE THE PATIENT WAS GOING TO THE TOILET.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
364045	NCB PERIPROSTHETIC DISTAL FEMUR PLATE, RIG		HRS	ZIMMER GMBH	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	80 YR		Hospitalization\| R