FDA Adverse Event Malfunction Summary report: N

SPECIAL TOTAL KNEE REPLACEMENT

MDR report key: 4373072 · Received December 24, 2014

Report

Report Number: 3004105610-2014-00171
Event Type: Malfunction
Date Received: December 24, 2014
Date of Event: April 24, 2014
Report Date: April 24, 2014
Manufacturer: STANMORE IMPLANTS WORLDWIDE LTD
Product Code: KRO
PMA / PMN Number: K120992
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

A REVIEW OF THE MANUFACTURING HISTORY CONFIRMS NO NON-CONFORMANCES WERE IDENTIFIED. THE DEVICE HAS NOT BEEN 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 SMILES TOTAL KNEE REPLACEMENT IMPLANT (K120992).

Additional Manufacturer Narrative · 1

PATIENT LABELS WERE MISSING FROM THE SHIPMENT. THE SURGERY WAS PERFORMED WITH NO REPORTED COMPLICATIONS. THE CUSTOM PRODUCT INSPECTION AND RELEASE PROCESS HAS BEEN UPDATED TO REQUIRE INSPECTION USING A SHIPMENT CHECKLIST, BY THE QUALITY ASSURANCE FUNCTION, TO ASSURE ACCURACY AND COMPLETENESS. THIS COMPLAINT IS BEING CLOSED AND IS BEING TRACKED AND TRENDED.

Description of Event or Problem · 1

IT WAS REPORTED BY THE SURGEON PRIOR TO THE PROCEDURE THAT THE PAPERWORK THAT IS ACCOMPANYING THE COMPONENT IS MISSING THE PATIENT LABELS.

Description of Event or Problem · 1

T WAS REPORTED BY THE SURGEON, PRIOR TO THE PROCEDURE, THAT THE PAPERWORK THAT WAS ACCOMPANYING THE COMPONENT IS MISSING THE PATIENT LABELS. (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
851092	SPECIAL TOTAL KNEE REPLACEMENT	LIMB SALVAGE SYSTEM	KRO	STANMORE IMPLANTS WORLDWIDE LTD	BME18579

Patients

Seq	Age	Sex	Outcome	Treatment
1	62 YR		Other