FDA Adverse Event Other Summary report: N

NEXGEN COMPLETE KNEE SOLUTION

MDR report key: 548062 · Received August 27, 2004

Report

Report Number
548062
Event Type
Other
Date Received
August 27, 2004
Date of Event
July 27, 2004
Report Date
August 26, 2004
Manufacturer
ZIMMER, INC.
Product Code
JWH
Report Source
User Facility report
Reporter Location
NY, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

PATIENT WITH DIAGNOSIS OF POST TRAUMATIC ARTHRITIS OF RIGHT KNEE UNDERWENT RIGHT TOTAL KNEE REPLACEMENT AND REMOVAL OF HARDWARE WITH ZIMMER CCK PROSTHESIS. ON X-RAY FOLLOWING CLOSURE IT WAS DISCOVERED THAT LEFT FEMORAL COMPONENT OF PROSTHESIS WAS INSERTED INSTEAD OF RIGHT COMPONENT. ASA-2. (ANESTHESIA SOCIETY OF AMERICA, STATUS: 2)COURSE:PATIENT TOLERATED PROCEDURE WELL. GETA (GENERAL ENDOTRACHEAL ANESTHESIA)NATURE OF INCIDENT: INSERTION OF WRONG SURGICAL IMPLANT. ISSUES TO BE ADDRESSED:VENDORS IN THE OPERATING/PROCEDURAL AREASVERIFICATION OF SITE/IMPLANT PROCEDURE-"TIME OUT"A THOUGHTFUL REVIEW OF THIS INCIDENT WAS CONDUCTED WITH THE KEY CLINICAL STAFF INVOLVED. THE ATTENDING ORTHOPAEDIST DESCRIBED IN DETAIL THE HISTORY OF THIS PATIENT'S FRACTURE. THE PATIENT HAD NOT BEEN ABLE TO AMBULATE BECAUSE OF TRAUMA SUFFERED ONE YEAR PRIOR TO THIS CURRENT SURGERY. THERE WAS EXTENSIVE SCLEROSIS AND DEFORMITY OF THE PROXIMAL TIBIA WITH SEVERE MEDIAL LATERAL COMPARTMENT OSTEOARTHRITIS. THE PATIENT HAS HAD A PREVIOUS KNEE REPLACEMENT, WHICH BECAME INFECTED WARRANTING NUMEROUS COURSES OF ANTIBIOTICS AS WELL AS SKIN GRAFTING. MANY ACADEMIC HOSPITALS IN THE AREA REFUSED TO OPERATE ON THIS PATIENT BECAUSE OF RISK. A UNIQUE PROSTHETIC SYSTEM WAS CHOSEN FOR THIS PATIENT BECAUSE OF THE POOR BONE STOCK AND LEVEL OF INJURY. THIS PROSTHESIS IS RARELY SEEN HERE AT THIS FACILITY. THE SALES VENDOR WAS IN THE OR, OPERATING ROOM, WITH THE PATIENT'S CONSENT. THE ORTHOPAEDIC TEAM HAD INITIALLY USED TRIAL PROSTHESIS TO MAKE SURE ALIGNMENT AND SIZE WAS APPROPRIATE. THE TRIAL WAS TESTED ON THE PATIENT AND ALL MEASUREMENTS HONED. THE INCISION WAS DONE. BONE PREPPED AND DRIED. THE SALES VENDOR WAS OBTAINING THE SIZE AND PARTICULAR PROSTHESIS REQUESTED FROM OUTSIDE THE OR. THE IMPLANT WAS ASSEMBLED BY THE VENDOR AND WAS HANDED TO SURGICAL RESIDENT WHO HANDED IT TO THE ATTENDING ORTHOPAEDIC SURGEON. THE BONE DID NOT OFFER RESISTANCE TO IMPLANT (AS WOULD HEALTHY BONE) BECAUSE OF POOR BONE STOCK. IF RESISTANCE WAS MET THE SURGICAL TEAM WOULD MOST LIKELY REALIZE THE ERROR. THE CIRCULATING NURSE BY POLICY WILL BE RESPONSIBLE FOR CHECKING LATERALITY OF THE DEVICE TO THE STERILE TEAM PRIOR TO HANDING OFF THE DEVICE. THE CIRCULATING NURSE IS RESPONSIBLE FOR PLANNING, COORDINATING, CONTROLLING AND CARRYING OUT THE PATIENT CARE ACTIVITIES SUPPORTIVE TO THE SURGICAL PROGRAM OF CARE. STAFF FUNCTIONS OUTSIDE THE SURGICAL FIELD AND ANTICIPATES AND PROVIDES NEEDED EQUIPMENT LIGHTING AND OTHER ELECTRICAL EQUIPMENT. THE VENDOR SHOULD NOT HAVE BEEN PERMITTED TO HAND THE DEVICE TO THE SURGEON. THE SURGICAL SERVICES VENDOR POLICY AND SURGICAL SERVICES MEMORANDA WERE REVIEWED REGARDING THIS ISSUE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 NEXGEN COMPLETE KNEE SOLUTION PROSTHESIS, KNEE JWH ZIMMER, INC. LEGACY KNEE-CONSTRAINED CONDYLAR LOCK FEMORAL COMPONENT OPTION 60137014

Patients

Seq Age Sex Outcome Treatment
1 62 YR