FDA Adverse Event Malfunction Summary report: N

CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT

MDR report key: 4364959 · Received December 19, 2014

Report

Report Number: 3004105610-2014-00100
Event Type: Malfunction
Date Received: December 19, 2014
Date of Event: July 22, 2013
Report Date: April 22, 2013
Manufacturer: STANMORE IMPLANTS WORLDWIDE LTD
Product Code: KRO
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

A REVIEW OF THE DEVICE HISTORY WAS PERFORMED AND NO NON-CONFORMANCES WERE IDENTIFIED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. REQUESTS ARE BEING MADE FOR ADDITIONAL INFORMATION AND A SUPPLEMENTAL REPORT WILL BE PROVIDED IF THIS INFORMATION IS RECEIVED. PLEASE NOTE THAT THIS CUSTOM IMPLANT IS SIMILAR TO THE METS MODULAR DISTAL FEMUR (K121029).

Additional Manufacturer Narrative · 1

A REVIEW OF THE DEVICE HISTORY WAS PERFORMED AND NO NON-CONFORMANCES WERE IDENTIFIED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE TIBIAL COMPONENT FRACTURED AFTER 7 ½ YEARS IN SITU. A NEW TIBIAL COMPONENT HAS BEEN SUCCESSFULLY IMPLANTED WITH NO REPORTED COMPLICATIONS. THIS COMPLAINT WILL BE TRACKED AND TRENDED. PLEASE NOTE THAT THIS CUSTOM IMPLANT... DEVICE NOT RETURNED TO MANUFACTURER.

Description of Event or Problem · 1

A SURGEON HAS REPORTED THAT THE TIBIAL COMPONENT OF A PATIENT'S CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT HAS FRACTURED.

Description of Event or Problem · 1

A SURGEON HAS REPORTED THAT THE TIBIAL COMPONENT OF A PATIENTS CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT HAS FRACTURED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
838293	CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT	LIMB SALVAGE SYSTEM	KRO	STANMORE IMPLANTS WORLDWIDE LTD	BME12099	BME12099

Patients

Seq	Age	Sex	Outcome	Treatment
1	46 YR		Other\| R