BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT A-14,CONSTRAINED

    MDR report key: 9675244 · Received February 6, 2020

    Report

    Report Number
    0009613350-2020-00054
    Event Type
    Injury
    Date Received
    February 6, 2020
    Date of Event
    November 12, 2010
    Report Date
    May 18, 2020
    Manufacturer
    ZIMMER GMBH
    Product Code
    JWH
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. ADDITIONAL: D10, H2, H6 CORRECTION: B4, B5, D6 (EMPTY), D11, G4, G7, H3, H10 EVENT SUMMARY: IT WAS REPORTED THAT THE PATIENT HAD A WALLABY III TOTAL KNEE PROSTHESIS IMPLANTED IN 2004 AFTER LOOSENING OF THE PRIMARY TKA PERFORMED IN 2002. IN 2010 A NEXGEN ALL POLY PATELLA WAS IMPLANTED IN ADDITION TO THE WALLABY III PROSTHESIS. IN 2019 THE WALLABY III PROSTHESIS WAS REVISED DUE TO DISLOCATION OF THE INSERT WITH LOOSENING OF THE FEMORAL COMPONENT AND COMPLETE INSTABILITY OF THE LIGAMENTS WITH KNEE JOINT SUBLUXATION AND LARGE FEMORAL DEFECT. REVIEW OF RECEIVED DATA - SURGICAL REPORT OF (B)(6) 2010 PRE-OPERATIVE DIAGNOSIS: RETRO-PATELLAR PAIN SYNDROME AFTER TOTAL KNEE ARTHROPLASTY (TKA) AND TKA REVISION RIGHT KNEE PROCEDURE: THE RIGHT KNEE JOINT IS OPENED. A PRONOUNCED SYNOVITIS IS FOUND. THE KNEE PROSTHESIS IS STABLE AND NOT LOOSE. THEREFORE, A SECONDARY RETRO-PATELLAR REPLACEMENT IS PERFORMED. A LATERAL RELEASE AND AN EXTENSIVE SYNOVECTOMY ARE EXECUTED. THE PATELLA¿S OSTEOPHYTES ARE RESECTED, THE PATELLA EQUATOR IS ADJUSTED WITH THE APPROPRIATE GAUGE AND THE PROTRUSION IS RESECTED WITH AN OSCILLATING SAW. DRILLING IS THEN PERFORMED FOLLOWED BY RINSING OF THE BONE. A 29 MM ALL POLY PATELLA IS PLACED AND HELD IN PLACE UNTIL THE CEMENT IS HARDENED. THE KNEE IS REDUCED AND A GOOD SLIDING MOVEMENT OF THE PATELLA IS SEEN. ACCORDING TO THE REPORT AND THE ACCOMPANIED PAGE WITH THE STICKERS OF THE PRODUCTS USED IN THE SURGERY THE FOLLOWING PATELLA COMPONENT WAS IMPLANTED: NEXGEN COMPLETE KNEE SOLUTION, ALL POLY PATELLA, SIZE 29, THICKNESS 8 MM, REF. NO. 5972-65-29, LOT NO. 61087899. - HOSPITAL DISCHARGE REPORT OF (B)(6) 2010 DIAGNOSIS: STATE AFTER TKA ON THE RIGHT SIDE IN 2002 STATE AFTER RIGHT TKA REVISION DUE TO LOOSENING IN 2004 ANAMNESIS: INCREASING PAIN IN THE RIGHT KNEE AFTER TKA REVISION IN 2004. THE INDICATION FOR SURGICAL REVISION AND PATELLA REPLACEMENT IS GIVEN. X-RAYS OF (B)(6) 2010: NO FRACTURE. METAL STAPLES ARE VISIBLE. PATELLA VIEW (B)(6) 2010: THE RIGHT PATELLA WITH PATELLA REPLACEMENT IS PROPERLY ALIGNED WITH THE RETRO-PATELLAR BEARING. THERE ARE NO AIR INCLUSIONS IN THE SOFT TISSUE. - X-RAYS AP AND ML X-RAYS TAKEN ON (B)(6) 2010 THE X-RAYS SHOW THE SITUATION OF THE WALLABY III KNEE PROSTHESIS BEFORE THE RETRO-PATELLAR REPLACEMENT WAS IMPLANTED. THE WALLABY III PROSTHESIS IS INCONSPICUOUS. THE PATELLA CANNOT BE SEEN IN THE X-RAYS. AP AND ML X-RAYS TAKEN ON (B)(6) 2010 COMPARED WITH THE PREVIOUS STUDY DATE METALLIC STAPLES ARE NOW VISIBLE IN BOTH VIEWS. IN THE ML VIEW THE PATELLA IS DISPLAYED, IT SEEMS TO HAVE AN INHOMOGENEOUS STRUCTURE. SKYLINE VIEW OF THE PATELLA TAKEN ON (B)(6) 2010 THE VIEW SHOWS THE PATELLA REPLACEMENT ALIGNED WITH THE RETRO-PATELLAR BEARING. METALLIC STAPLES ARE VISIBLE. DEVICES ANALYSIS VISUAL EXAMINATION OF THE RETRIEVALS EXPLANTED IN 2019 CAN BE FOUND WITHIN CMP- (B)(4) . PRODUCT EVALUATION WOULD NOT CONTRIBUTE TO THIS INVESTIGATION, AST THE EXPLANTATION WAS PERFORMED ALMOST 9 YEARS AFTER THIS EVENT. REVIEW OF PRODUCT DOCUMENTATION - ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. - DHR REVIEW: THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. CONCLUSION SUMMARY THE PATIENT HAD A WALLABY III TOTAL KNEE PROSTHESIS IMPLANTED IN 2004 AFTER LOOSENING OF THE PRIMARY TKA PERFORMED IN 2002. IN 2010 A NEXGEN ALL POLY PATELLA WAS IMPLANTED IN ADDITION TO THE WALLABY III PROSTHESIS. COMBINATION OF KNEE COMPONENTS FROM TWO DIFFERENT KNEE SYSTEMS (I.E. WALLABY AND NEXGEN) IS NOT ALLOWED AND HAS TO BE CONSIDERED OFF-LABEL USE. IN 2019 THE WALLABY III PROSTHESIS WAS REVISED DUE TO DISLOCATION OF THE INSERT WITH LOOSENING OF THE FEMORAL COMPONENT AND COMPLETE INSTABILITY OF THE LIGAMENTS WITH KNEE JOINT SUBLUXATION AND LARGE FEMORAL DEFECT. THE REVISION OF 2019 IS ADRESSED IN CMP- (B)(4) . THE INVESTIGATION RESULTS DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION PAIN CANNOT BE RELATED TO A SINGLE SPECIFIC FAILURE MODE AND CAN HAVE NUMEROUS ROOT CAUSES. BASED ON THE GIVEN INFORMATION, WE WERE NOT ABLE TO IDENTIFY AN EXACT ROOT CAUSE FOR THIS ISSUE. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4) .

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WHICH WAS RECEIVED ON JAN 31, 2020. THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE PREVIOUS MEDWATCH. THE MANUFACTURER RECEIVED SURGICAL REPORT FOR REVIEW. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE OR AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IN 2010 A PATIENT WAS IMPLANTED A NEXGEN ALL POLY PATELLA IN ADDITION TO THE WALLABY III PROSTHESI WHICH SHE RECEIVED IN 2004.

    Description of Event or Problem · 0

    PATIENT WAS IMPLANTED ON AN UNKNOWN SIDE AND UNDERWENT REVISION DUE TO PAIN.

    Additional Manufacturer Narrative · 1

    MEDICAL PRODUCT: TIBIAL MET. BACK FOR STEM 68-AB; ITEM#41276801; LOT#2193201; WALLABY ANCHORAGE STEM; ITEM#412600063; LOT#2121191; REVISION FEM. COMPONENT A-RIGHT; ITEM#43264011; LOT#2141615; WALLABY ANCHORAGE STEM; ITEM#412600063; LOT#2038586. THE MANUFACTURER DID NOT RECEIVE X-RAYS FOR REVIEW. 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).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED ON AN UNKNOWN SIDE AND UNDERWENT REVISION DUE TO UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138917 TIBIAL INSERT A-14,CONSTRAINED TIBIAL INSERT A-14,CONSTRAINED JWH ZIMMER GMBH N/A 2129007

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10 NARRATIVE