FDA Adverse Event Injury Summary report: N

TOTAL KNEE REPLACEMENT

MDR report key: 7217969 · Received January 25, 2018

Report

Report Number: 3004105610-2018-00009
Event Type: Injury
Date Received: January 25, 2018
Date of Event: January 3, 2018
Report Date: April 26, 2018
Manufacturer: STANMORE IMPLANTS WORLDWIDE
Product Code: KRO
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GB
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 0

THE INVESTIGATION HAS IDENTIFIED THAT THE TIBIAL CEMENTED STEM FROM PIN (B)(4) WAS INSERTED BUT THE SURGEON RETURNED THE CUSTOM FEMORAL COMPONENTS UNUSED AND INSERTED A METS DISTAL FEMUR INSTEAD. THE IN-SITU IMPLANT THEREFORE CONSISTS OF A METS DISTAL FEMUR CONNECTED TO THE CUSTOM TIBIAL STEM FROM PIN (B)(4). THE REPORTED LOOSENING REFERS TO THE METS DISTAL FEMUR FEMORAL STEM. AS THERE IS NO INDICATION THAT THE TIBIAL STEM FROM PIN (B)(4) HAS LOOSENED IT CAN BE CONSIDERED TO BE A CONCOMITANT DEVICE AND THEREFORE NOT MDR REPORTABLE. MFR REPORT # 3004105610-2018-00034 HAS BEEN SUBMITTED FOR THE METS DISTAL FEMUR DEVICE.

Description of Event or Problem · 0

A NEW PRESCRIPTION FORM HAS BEEN RECEIVED FOR A REVISION DEVICE DUE TO ASEPTIC LOOSENING.

Additional Manufacturer Narrative · 1

AN INVESTIGATION IS BEING PERFORMED IN AN ATTEMPT TO IDENTIFY THE CAUSE OF THE EVENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. PLEASE NOTE THAT THIS CUSTOM DEVICE IS SIMILAR TO THE METS SMILES TOTAL KNEE REPLACEMENT (K120992). DEVICE NOT AVAILABLE.

Description of Event or Problem · 1

A NEW PRESCRIPTION FORM HAS BEEN RECEIVED FOR A REVISION DEVICE DUE TO ASEPTIC LOOSENING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
61773	TOTAL KNEE REPLACEMENT	LIMB SALVAGE SYSTEM	KRO	STANMORE IMPLANTS WORLDWIDE		PIN 16229

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR		Required Intervention