FDA Adverse Event Injury Summary report: N

CUSTOM TOTAL FEMUR REPLACEMENT IMPLANT

MDR report key: 4390421 · Received December 24, 2014

Report

Report Number: 3004105610-2014-00169
Event Type: Injury
Date Received: December 24, 2014
Date of Event: April 14, 2014
Report Date: April 8, 2014
Manufacturer: STANMORE IMPLANTS WORLDWIDE LTD.
Product Code: KRO
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

A REVIEW OF THE MANUFACTURING HISTORY CONFIRMS NO CONFORMANCES WERE IDENTIFIED. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE SURGEON COMMENTED THAT THERE WAS NO FAILURE OF THE DEVICE. 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 TOTAL FEMUR REPLACEMENT IMPLANT (K121055).

Additional Manufacturer Narrative · 1

THE DEVICE WAS NOT RETURNED AND THERE WAS NO INDICATION AS TO WHY AN INFECTION OCCURRED. THE PATIENT UNDERWENT SUCCESSFUL REVISION TO A TOTAL FEMUR. THE SURGERY WAS REQUIRED DUE TO A PATIENT INFECTION. THE REVISION SURGERY WAS COMPLETED WITH NO REPORTED COMPLICATIONS. THIS COMPLAINT IS BEING CLOSED, AND IS BEING TRACKED AND TRENDED

Description of Event or Problem · 1

IT WAS REPORTED BY THE SURGEON THAT THE PATIENT UNDERWENT A TOTAL FEMUR REPLACEMENT PROCEDURE ON (B)(6) 2008 AND SUBSEQUENTLY WAS REVISED ON (B)(6) 2014 DUE TO AN INFECTION.(B)(4).

Description of Event or Problem · 1

IT WAS REPORTED BY THE SURGEON THAT THE PATIENT UNDERWENT A TOTAL FEMUR REPLACEMENT PROCEDURE ON (B)(6) 2008 AND SUBSEQUENTLY WAS REVISED ON (B)(6) 2014 DUE TO AN INFECTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
850197	CUSTOM TOTAL FEMUR REPLACEMENT IMPLANT	TOTAL FEMUR REPLACEMENT	KRO	STANMORE IMPLANTS WORLDWIDE LTD.	BME13737

Patients

Seq	Age	Sex	Outcome	Treatment
1	22 YR		Required Intervention