BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METASUL TAPER LINER JJ/40

    MDR report key: 7380620 · Received March 29, 2018

    Report

    Report Number
    0009613350-2018-00395
    Event Type
    Injury
    Date Received
    March 29, 2018
    Date of Event
    May 26, 2016
    Report Date
    August 20, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    PMA / PMN Number
    PK091973
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: METASUL HEAD 40, 12/14, SIZE M /0, 00-8770-040-02, 2547669; SHELL WITH CLUSTER HOLES POROUS 54 MM O.D. SIZE JJ FOR USE WITH JJ LINERS, 00-8757-054-01, 61430661; BONE SCREW SELF-TAPPING 6.5 MM DIA. 30 MM LENGTH, 00625006530, 61412736; STEM NH COLLARED 12/14 5 L, 7354-01-205, 60839449. THE FOLLOWING REPORT IS ASSOCIATED WITH THIS EVENT: 0009613350-2018-00268. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY INVESTIGATION RESULT. DHR REVIEW: THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: METALLOSIS. NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: PAIN. EVENT DESCRIPTION: A PATIENT IS PURSUING A LEGAL CASE. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A MOM HIP AND UNDERWENT A REVISION SURGERY AROUND 6 YEARS POST IMPLANTATION DUE TO PAIN AND METALLOSIS REVIEW OF RECEIVED DATA: OPERATIVE REPORT OF IMPLANTATION, SURGERY DATE: (B)(6) 2010. PREOPERATIVE DIAGNOSIS: OLD SLIPPED CAPITAL FEMORAL EPIPHYSIS WITH SUBSEQUENTLY OSTEOARTHRITIS OF THE LEFT HIP. POSTOPERATIVE DIAGNOSIS: SAME OPERATION: LEFT THA. DESCRIPTION OF PROCEDURE:RETRACTORS WERE PLACED TO EXPOSE THE ACETABULUM, WHERE THERE WERE FOUND TO BE VERY LARGE LOOSE OSTEOPHYTES OVERLYING THE ANTERIOR AND INFERIOR ASPECTS OF THE ACETABULUM. THERE WERE EXCISED. REAMING WAS CARRIED OUT. X-RAYS REVEALED SATISFACTORY POSITION (OF TRIAL PROSTHESES).CUP WAS TAPPED IN PLACE. IT WAS CHECKED FOR ALIGNMENT AND FOUND TO BE SATISFACTORY. ATTENTION WAS THEN TURNED TO THE PROXIMAL FEMUR. IT WAS FOUND THAT SIZE 5 FEMORAL PROSTHESIS FIT EXCELLENT. THE MOST STABILITY WAS WITH A NEUTRAL HEAD AND NECK LENGTH. X-RAYS WERE TAKEN AFTER REDUCING THE HIP JOINT AND X-RAYS WERE TAKEN IN THE AP POSITION WITH SATISFACTORY POSITION OF THE COMPONENTS. OPERATIVE REPORT OF EXPLANTATION, SERVICE DATE: (B)(6) 2016 (THIS IS A DISCREPANCY TO THE DATE (B)(6) 2016 REPORTED BY ZIMMER BIOMET LEGAL DEPARTMENT.) PREOPERATIVE DIAGNOSIS: LEFT HIP PAIN SECONDARY METALLOSIS LEFT HIP CAUSED BY METAL AND METAL ARTICULATING SURFACES. POSTOPERATIVE DIAGNOSIS: SAME. PROCEDURE: REVISION ACETABULAR COMPONENT LEFT THA. DESCRIPTION OF PROCEDURE: FIBROUS AND SCAR TISSUE WAS REMOVED TO ALLOW ADEQUATE VISUALIZATION OF THE ACETABULAR COMPONENT AND ACTIVE ARTICULATION DUAL MOBILITY BEARING WITH ULTRA HIGHWAY POLYETHYLENE WAS IMPACTED IN TO THE ACETABULAR SHELL...IT WAS ELECTED TO PURSUE THIS OPTION DUE TO THE AGE OF THE PATIENT AND THERE BEING A WELL SEATED ACETABULAR COMPONENT WHICH HAD ADEQUATE ABDUCTION BUT DID LACK A LITTLE BIT ANTEVERSION BUT SIGNIFICANTLY SIMPLIFIED THIS SURGICAL PROCEDURE ACCOMPLISHING OUR GOAL OF CHANGING OUT THE METAL ON METAL ARTICULAR SURFACES EVENT THOUGH THIS WAS AN OFF LABEL US (NOTE: SURGEON IS SPEAKING ABOUT THE COMBINATION OF THE BIOMET DUAL MOBILITY BEARING WITH ZIMMER BIOLOX HEAD). FOLLOWING THIS, A BIOLOCK (NOTE: THIS IS A TYPO; A BIOLOX IT IS ACCORDING TO PNS) CERAMIC HEAD WAS IMPACTED ON TO THE TRUNNION AND THE HIP WAS ATRAUMATICALLY REDUCED. TAKEN IMAGES SHOWED THERE WAS A LACK OF GOOD RESTORATION OF OFFSET BUT EXCELLENT RESTORATION OF LEG LENGTH. IT WAS CHOSEN NOT TO MAKE ADDITIONAL CHANGES. DEVICE ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS REVIEW OF PRODUCT DOCUMENTATION: THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING SAP RMW: IMPLANT BREAKAGE, INCREASED WEAR (EG M-O-M ARTICULATION) DUE TO INSUFFICIENT DESCRIPTION OF SURGICAL PROCESS LEADS TO INTRAOPERATIVE ERRORS OR MISUSE OF IMPLANT OUTSIDE OF ITS SCOPE (EG RE-USE, USE BEYOND EXPIRY DATE, FOREIGN PARTICLES IN ARTICULATION (BONE CEMENT, METAL DEBRIS, CERAMIC PARTICLES) => POSSIBLE, SINCE NO DEVICE WAS RECEIVED FOR INVESTIGATION, THE CONDITION OF THE DEVICE IS UNKNOWN. IT CANNOT BE EXCLUDED THAT NO FOREIGN PARTICLES REMAINED IN ARTICULATION DURING IMPLANTATION SURGERY. IT IS POSSIBLE A 3RD BODY DEBRIS LEFT BETWEEN MAY LEAD TO SURFACE DEFECTS. THEREFORE, THIS CAUSE CANNOT BE EXCLUDED. IMPLANT BREAKAGE, INCREASED WEAR (EG M-O-M ARTICULATION), LOSS OF CONNECTION BETWEEN COMPONENTS DUE TO INSUFFICIENT DESCRIPTION OF SURGICAL PROCESS LEADS TO INTRAOPERATIVE ERRORS OR MISUSE OF IMPLANT OUTSIDE OF ITS SCOPE (IMPLANT PARTICLES REMAIN IN BODY AFTER REVISION ) NOT POSSIBLE -> THE IMPLANTATION WAS FOR PRIMARY SURGERY. NO REVISION SURGERY WAS PERFORMED AT THIS TIME. THEREFORE, THIS CAUSE CAN BE EXCLUDED. METAL DEBRIS, BREAKAGE OF INSERT, STEM NECK FRACTURE, DISLOCATION OR LUXATION, OSTEOLYSIS / METALLOSIS DUE TO INAPPROPRIATE DESIGN CONCERNING RANGE OF MOTION LEADING TO IMPINGEMENT OF COMPONENTS NOT POSSIBLE -> A SYSTEMATIC ISSUE WITH DESIGN WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. ASEPTIC LOOSENING, METALLOSIS, SOFT TISSUE DAMAGE DUE TO METAL PARTICLE WEAR DUE TO M-O-M ARTICULATION (CLEARANCE) =>POSSIBLE, SINCE NO DEVICE WAS RECEIVED FOR INVESTIGATION, THE CONDITION OF THE DEVICE IS UNKNOWN. IT IS UNKNOWN IF WEAR OF HAS OCCURED, THIS CANNOT BE MEASURED WITHOUT THE DEVICES. THEREFORE, THIS CAUSE CANNOT BE EXCLUDED. POSTOPERATIVE TISSUE REACTION ON BURRS / SHARP EDGES. METALLOSIS DUE TO DESIGN SPECIFICATION NOT MET NOT POSSIBLE -> THE DEVICE MANUFACTURING CONCLUSION: IT IS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY OF A MOM THA TO CHANGE TO A CERAMIC/POLYETHYLENE. IT IS UNKNOWN HOW THE REPORTED METALLOSIS WAS DETECTED, NO LAB REPORTS ARE AVAILABLE. THE SURGICAL REPORT OF EXPLANT DID NOT STATE INTRA OPERATIVE FINDINGS OF METALLOSIS. NO DEVICES OR PHOTOS OF THE EXPLANTED IMPLANTS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. IN CONCLUSION, DUE TO SIGNIFICANT LACK OF INFORMATION, IT IS IMPOSSIBLE TO PERFORM A MEANINGFUL ANALYSIS OF THE REPORTED EVENT. THEREFORE, AN EXACT ROOT CAUSE CANNOT BE DETERMINED THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED 6 YEARS POST IMPLANTATION DUE TO PAIN AND METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223963 METASUL TAPER LINER JJ/40 METASUL TAPER LINERS, METASUL FEMORAL HEADS KWA ZIMMER GMBH N/A 2517952

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R