BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METASUL, ALPHA INSERT, HH/28

    MDR report key: 7573103 · Received June 6, 2018

    Report

    Report Number
    0009613350-2018-00592
    Event Type
    Injury
    Date Received
    June 6, 2018
    Date of Event
    September 14, 2015
    Report Date
    September 5, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    PMA / PMN Number
    PNA
    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

    THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: WEAR, OSTEOLYSIS, INLAY-DISLOCATION. EVENT DESCRIPTION (EVENT DETAILS, PER) - EVENT SUMMARY: IT WAS REPORTED THAT A PATIENT, BORN IN 1957, WAS IMPLANTED WITH ZB PRODUCTS ON (B)(6) 2004 ON THE RIGHT HIP AND REVISED ON (B)(6) 2015 DUE TO WEAR AND DISLOCATION OF THE INLAY AND OSTEOLYSIS AROUND THE CUP WITH LOOSENING AND MILD OSTEOLYSIS AROUND A STABLE STEM WHICH WAS LEFT IN SITU. REVIEW OF RECEIVED DATA - ONE X-RAY HAS BEEN RECEIVED. THE X-RAY WAS TAKEN ON (B)(6) 2015 PRIOR TO REVISION OF THE RIGHT HIP PERFORMED ON (B)(6) 2015. X-RAY (B)(6) 2015 PELVIC AP VIEW: X-RAY QUALITY SUFFICIENT FOR EVALUATION. VISIBLE CEMENTLESS HIP TEP RIGHT AND LEFT. CUP INCLINATION ANGLE RIGHT 58° AND ORTHOGRADE POSITIONED STEM. GREAT EXTENT OF OSTEOLYSIS OF THE ACETABULUM AROUND THE IMPLANT AND TO A LESSER EXTENT IN THE AREA OF MEDIAL AND LATERAL STEM SHOULDER. DISLOCATION OF THE FEMUR HEAD TO CRANIAL. - ONE SURGICAL REPORT HAS BEEN RECEIVED REPORTING THE REVISION SURGERY PERFORMED ON (B)(6) 2015. SURGICAL REPORT (B)(6) 2015: INDICATION: LOOSENING, GREAT EXTENT OF OSTEOLYSIS AND RADIOLOGICAL INDICATION OF PAPROSKY DEFECT TYP 2B. SURGERY: REVISION OF HIPTEP RIGHT. UPON OPENING OF THE ARTICULAR CAPSULE REMOVAL OF LIGHT BLACKISH TISSUE SUGGESTING A M-O-M ARTICULATION SYNOVITIS. STEM SEEMED STABLE DURING REMOVAL OF THE HEAD. FURTHER REMOVAL OF SCARRED TISSUE FROM THE BOTTOM OF THE CUP. INLAY DAMAGED IN TERMS OF A TO CRANIAL MEDIAL DISLODGED METASUL-INLAY. UPON REAMING VISIBLE PAPROSKY TYP 2B DEFECT. DUE TO THE DEFECT IMPLANTATION OF A WEDGE-SYSTEM, MADE FROM TWO FEMUR HEADS RECEIVED FROM THE BONE BANK. PLACEMENT IN DIRECTION OF THE PUBIS. IMPLANTATION OF THE WEDGE IN COMBINATION WITH THE CUP AND FIXATION WITH SCREWS. FINALLY, IMPLANTATION OF THE TMT-CUP WITH A CEMENT LAYER BETWEEN THE WEDGE AND THE TMT-CUP. IMPACTION OF THE TMT-CUP AND FIXATION WITH TWO AUGMENTATIONS SCREWS. INSERTION OF THE INLAY, REPOSITION WITH A HEAD SIZE S. STABLE SITUATION WITH A GENTLE ELONGATION OF THE LEG. MOUNTING OF A BIOLOX-OPTION HEAD SIZE S. STABLE SITUATION DURING REPOSITION. - ONE CONSULTATION REPORT, DATED (B)(6) 2015, HAS BEEN RECEIVED, WITH NO ADDITIONAL, RELEVANT INFORMATION. - ONE REDUNDANCY LETTER, DATED(B)(6) 2015, HAS BEEN RECEIVED WITH NO ADDITIONAL, RELEVANT INFORMATION. DEVICE ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. ACCORDING TO THE INFORMATION RECEIVED, THE SURGEON RETAINED THE DEVICE. REVIEW OF PRODUCT DOCUMENTATION - THE COMPATIBILITY CHECK WAS PERFORMED FROM WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. ROOT CAUSE ANALYSIS ROOT CAUSE DETERMINATION USING SAP RMW: - ASEPTIC LOOSENING, OSTEOLYSIS DUE TO PE WEAR DUE TO MOTION BETWEEN INSERT AND SHELL => POSSIBLE, AS ACCORDING TO THE SURGICAL REPORT THE METASUL INLAY WAS DISLODGED. - MIGRATION, DETACHMENT OF CERAMIC OR METAL PART IN POLYETHYLENE (SANDWICH CONSTRUCTION) DUE TO CREEPING OF POLYETHYLENE, LOSS OF FUNCTION => POSSIBLE, AS THIS CAUSE CANNOT BE EXCLUDED BASED ON THE GIVEN INFORMATION. - ADVERSE BODY REACTION DUE TO METAL PARTICLES RELEASE (FRETTING BETWEEN SHELL AND STEM) LEADING TO SOFT TISSUE REACTION AND DAMAGE DUE TO IMPINGEMENT WITH STEM, LEADING TO DETACHMENT OF SANDWICH CONSTRUCTION, WEAR ON STEM NECK => POSSIBLE, AS IMPINGEMENT WITH STEM CANNOT BE EXCLUDED BASED ON THE INFORMATION GIVEN. - ASEPTIC LOOSENING, METALLOSIS, SOFT TISSUE DAMAGE DUE TO INAPPROPRIATE DESIGN CONCERNING TRIBOLOGICAL PERFORMANCE LEADING TO INCREASED WEAR PARTICLES FROM ARTICULATION => NOT POSSIBLE, AS A SYSTEMATIC ISSUE WITH DESIGN WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. - POSTOPERATIVE TISSUE REACTION DUE TO INSUFFICIENT MANUFACTURING PROCESS => NOT POSSIBLE, AS THE DHR REVIEW DID NOT REVEAL AN INSUFFICIENT MANUFACTURING PROCESS AND AS SUCH AN ISSUE WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. CONCLUSION SUMMARY BASED ON THE RECEIVED X-RAY AND THE SURGICAL REPORT THE REPORTED EVENT COULD BE CONFIRMED. REVIEW OF THE RECEIVED MEDICAL DATA (ONE X-RAY (B)(6) 2015 PELVIS AP VIEW, ONE CONSULTATION REPORT (B)(6) 2015, ONE SURGICAL REPORT (B)(6) 2015 AND ONE REDUNDANCY LETTER (B)(6) 2015) WAS PERFORMED BY OUR HCP. ACCORDING TO THE RESULT OF THE ANALYSIS THE FOLLOWING SITUATION WAS PRESENT AFTER 11 YEARS IN-VIVO OF A CEMENTLESS METALL-METALL ARTICULATION. RADIOLOGICAL INDICATION WAS GIVEN FOR A GREAT EXTENT OF OSTEOLYSIS IN THE ACETABULUM AROUND THE IMPLANT AND AT THE BEGINNING OF THE STEM. A HIGH-ANGLE CUP POSITION WITH A DECENTRALIZED FEMUR HEAD IS VISIBLE. ACCORDING TO THE SURGICAL REPORT TISSUE IRRITATION DUE TO METALLIC ABRASION AND A MASSIVE OSTEOLYSIS OF THE ACETABULUM WITH A PAPROSKY DEFECT TYP 2B. CONFIRMATION OF A CRANIAL METASUL-INLAY DISLOCATION. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. HOWEVER, THE IMPLANTATION TIME OF 11 YEARS IN A RATHER YOUNG PATIENT BORN 1957 MUST BE TAKEN INTO ACCOUNT. FURTHER, ESPECIALLY THE HIGH-ANGLE POSITION OF AROUND 58° OF THE CUP MAY HAVE ACCELERATED THE WEARING PROCESS AS DUE TO THE STEEP ANGLE HIGHER MECHANICAL FORCES ARE ENCOUNTERED AT CERTAIN AREAS OF THE ACETABULUM. UNFORTUNATELY, NO PREVIOUS X-RAY IMAGES ARE AVAILABLE FOR EVALUATION OF THE COURSE OF THE CUP POSITION AND THE OSTEOLYSIS OVER TIME. THE HIGHLY DEVELOPED OSTEOLYSIS MAY HAVE MANY REASONS. THEREFORE, BASED ON THE COMPLEX MEDICAL SITUATION A SPECIFIC ROOT CAUSE FOR THE OSTEOLYSIS AND THE INLAY DISLOCATION COULD NOT BE DETERMINED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER BIOMET CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K013935. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. X-RAY AND SURGICAL REPORTS WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. 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). THE FOLLOWING REPORT IS ASSOCIATED WITH THIS EVENT: METASUL, ALPHA INSERT, HH/28, 0009613350-2018-00593: ECHO BI-MTRC MICR RP SO 5X73, 0009613350-2018-00595: OPTAN, STEM, RIGHT, UNCEMENTED, 16, TAPER 12/14.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY APPROXIMATELY ELEVEN YEARS POST IMPLANTATION DUE TO WEAR AND DISLOCATION OF THE INLAY AND OSTEOLYSIS AROUND THE CUP WITH LOOSENING AND MILD OSTEOLYSIS AROUND A STABLE STEM WHICH WAS LEFT IN SITU. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415658 METASUL, ALPHA INSERT, HH/28 KWA ZIMMER GMBH N/A 2208633

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R ACA CAP, ITEM# 409.0145, LOT# 2190014| ECHO-BI, ITEM# 19.28.05, LOT# 2199611| OPTANA STEM, ITEM# 01.00063.016, LOT# 2189509| ACA CAP, ITEM# 409.0145, LOT# 2190014| ECHO-BI, ITEM# 19.28.05, LOT# 2199611| OPTANA STEM, ITEM# 01.00063.016, LOT# 2189509