FDA Adverse Event Malfunction Summary report: N

BIOMET, INC

MDR report key: 2503368 · Received March 15, 2012

Report

Report Number
2503368
Event Type
Malfunction
Date Received
March 15, 2012
Date of Event
March 6, 2012
Report Date
March 8, 2012
Manufacturer
BIOMET
Product Code
JDI
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MT, US

Narratives

Description of Event or Problem · 1

PATIENT: REVISION TOTAL HIP ARTHROPLASTY. HISTORY: IN THE FALL OF 2008 PATIENT UNDERWENT LEFT (LT) TOTAL HIP ARTHROPLASTY - ANTERIOR. ELEVEN (11) MONTHS LATER UNDERWENT A REVISION LT TOTAL HIP ARTHROPLASTY. IN THE WINTER OF 2011 PATIENT UNDERWENT A BONE SCAN. AS OF EARLY 2012 PATIENT HAD CONTINUED PAINFUL LEFT TOTAL HIP ARTHROPLASTY: DIFFERENTIAL DIAGNOSIS INCLUDES ASEPTIC LOOSENING VERSUS LOW GRADE INDOLENT SEPTIC LOOSENING. TO DATE ALL STUDIES LOOKING FOR INFECTION HAVE BEEN NEGATIVE HOWEVER, PATIENT HAS A HISTORY OF A POSITIVE CULTURE. BONE SCAN SHOWS INCREASED UPTAKE WHICH MAY REPRESENT LOOSENING WHICH IS ASEPTIC VERSUS A VERY LOW-GRADE INFECTION. SURGERY EARLY IN 2012: PATIENT PREPARED...SCIATIC NERVE PALPATED, PROTECTED; FOLLOWED TRACK SYNOVIAL FLUID WHICH WENT DIRECTLY TO THE HIP JOINT. NO SIGNS OF INFECTION, NO PURULENCE. PATIENT FOUND TO HAVE SOME FAINT BLACK STAINING WITH EVIDENCE OF SOME RESIDUAL METALLOSIS WHICH WAS EXTENSIVELY DEBRIDED. MULTIPLE SPECIMENS AROUND IMPLANT SENT FOR FROZEN SECTION WHICH CAME BACK NEGATIVE FOR ROUTINE CULTURES AS WELL AS POLYMERASE CHAIN REACTION(PCR) TEST. HIP DISLOCATED, HEAD REMOVED FROM PROSTHESIS...NOTED TO BE GROSS ROTATION OF FEMORAL COMPONENT. THERE WAS ALSO SEVERE OSTEOLYSIS GLOBALLY AROUND THE POROUS METAL PROXIMALLY. DESPITE THIS, WITH MULTIPLE ATTEMPTS, THE STEM COULD NOT BE DISENGAGED FROM THE FEMORAL CANAL AND IT WAS FELT THAT THIS WAS DUE TO THE DISTAL FIXATION. IT WAS FELT THAT THERE WAS SOME PLASTIC DEFORMATION WHICH WAS ALLOWING FOR ROTATION PROXIMALLY BUT DISTALLY IT WAS WELL FIXED BASED ON BOTH THE INTRAOPERATIVE FINDINGS AS WELL AS THE PREOPERATIVE XRAY. BASED ON THIS IT WAS ELECTED TO DO AN EXTENDED TROCANTERIC OSTEOTOMY. DONE WITHOUT COMPLICATION, THE STEM WAS FOUND TO BE VERY TIGHT IN THE DISTAL 2/3 BUT HAD NO INGROWTH PROXIMALLY. FOREIGN BODY REACTION WAS FOUND PROXIMALLY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 BIOMET, INC POLY HIP LINING JDI BIOMET ACETAB EP-108525 247970

Patients

Seq Age Sex Outcome Treatment
1 66 YR