BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METASUL HD 28MM L 12/14

    MDR report key: 9966416 · Received April 16, 2020

    Report

    Report Number
    0009613350-2020-00194
    Event Type
    Injury
    Date Received
    April 16, 2020
    Date of Event
    September 19, 2019
    Report Date
    January 29, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    KWA
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. D11: ITEM: 01.00024.454; NAME: FITMORE, SHELL WITH FINS, UNCEMENTED, 54/JJ; LOT: 2051036. ITEM: 01.00010.410; NAME: METASUL, ALPHA INSERT, JJ/28; LOT: 2051858. ITEM: 29.00.09-112; NAME: CLS SPOTORNO, STEM, 145°, UNCEMENTED, 11.25, TAPER 12/14; LOT: 2061619. EVENT DESCRIPTION: IT WAS REPORTED THE PATIENT HAD THE INITIAL HIP SURGERY ON THE LEFT SIDE ON (B)(6) 2001. ON (B)(6) 2019, PATIENT HAD A REVISION SURGERY DUE TO A FALL, WHICH CAUSED A FRACTURE OF THE ACETABULAR TYPE B3 AS WELL AS A FRACTURE OF THE PROXIMAL FEMUR. ADDITIONALLY, PRE-SURGICAL BLOOD MEASUREMENT OF CO & CR SHOWED ELEVATED LEVELS. REVIEW OF RECEIVED DATA: MEDICAL DATA RELEVANT TO THE CASE HAS BEEN RECEIVED AND REVIEWED AND SUMMARIZED BY AN HCP. X-RAYS: ONE X-RAY, DATED ON (B)(6) 2007 SHOWS THE LEFT HIP IN AXIAL VIEW. RADIOLUCENT LINE IN THE LOWER ACETABULUM BOUNDED BY A SCLEROTIC LINE CAN BE OBSERVED. ADVANCED FEMORAL HEAD NECROSIS OF THE CONTRALATERAL HIP. THREE X-RAYS WERE RECEIVED TAKEN ON (B)(6) 2019, SHORTLY BEFORE REVISION (2X PELVIC OVERVIEW & 1X LEFT HIP AXIAL-VIEW): IMAGES WERE PERFORMED IN BED. PROTRUSION OF THE CUP TO THE MINOR PELVIS WITH SUSPECTED DEFECT OF THE BONY BORDER AT THE BOTTOM OF THE ACETABULUM CAN BE OBSERVED AS WELL AS LARGE RADIOLUCENT AREA AT THE PROXIMAL FEMUR IN GRUEN ZONE 1 AND 7 BOUNDED BY A SCLEROTIC LINE. DISLOCATED DIAPHYSEAL FEMORAL FRACTURE CAN ALSO BE OBSERVED ON ALL OF THE X-RAYS. SURGICAL REPORT: SURGICAL REPORT, DATED ON (B)(6) 2019: THE SURGICAL REPORT DESCRIBED THAT AFTER PRIMARY IMPLANTATION NO FOLLOW-UP CHECK WAS PERFORMED FOR A LONG TIME. THERE IS ALSO A REPORT OF A FALL THAT LED TO A PERIPROSTHETIC FRACTURE OF THE ACETABULUM AND LEFT FEMUR. THE ACETABULUM SHOWS OSTEOLYSES WITH A CRITICAL DEFECT IN THE ANTERIOR WALL AND FRACTURE LINES THAT ARE DIFFICULT TO IDENTIFY AND THE CUP TILTED DUE TO THE TRAUMA IN A CURRENTLY NON-FUNCTIONAL POSITION. THERE IS A SPIRAL FRACTURE ON THE STEM WITH A FRACTURE WEDGE AT THE HEIGHT OF THE TIP OF THE STEM WITH A REALLY STABLE STEM. DUE TO THE NECESSARY COMPLEX RECONSTRUCTION OF THE ACETABULUM, A COMPLETE REPLACEMENT OF THE PROSTHESIS IS NECESSARY VIA A TRANSFEMORAL APPROACH. METALLOSIS DRAINS OUT OF THE JOINT AND THE THICKENED CAPSULE IS INTERSPERSED WITH PRONOUNCED METALLOSIS ON THE JOINT SIDE. ON THE POSTERIOR NECK OF THE PROSTHESIS THERE IS A MACROSCOPIC EVIDENCE OF A NOTCH ABOUT 1/3 OF THE DIAMETER OF THE NECK DUE TO THE IMPINGEMENT WITH THE METAL CUP. ALTHOUGH THE CUP IS CLEARLY LOOSE, IT IS VERY DIFFICULT TO REMOVE IT. AS EXPECTED, AFTER REMOVING THE CUP, THE ANTERIOR WALL IS DEFECTIVE AND THE POSTERIOR WALL IS INTACT. THE ACETABULAR ROOF SHOWS A BONE DEFECT OF MORE THAN 5 CM IN DIAMETER IN THE CRANIO-CAUDAL REGION, IT HAS SEVERAL CENTRAL DEFECTS, THE POSTERIOR WALL DEFECT IS LARGER THAN EXPECTED. THE SPIRAL FRACTURE WITH FRACTURE WEDGE AT THE LEVEL OF THE STEM'S TIP IS SEVERELY DISPLACED, OSTEOLYSES ARE CURETTED OUT IN THE PROXIMAL FEMUR. AFTER CEMENTING OF A MÜLLER FLAT ROOF PROFILE DURASUL 58/36 CUP AT APPROXIMATELY 45 DEGREES INCLINATION AND 20 DEGREES ANTEVERSION, THE FRACTURE IS OSTEOSYNTHESIZED WITH CERCLAGE WIRES AND SUBSEQUENTLY A CURVED REVITAN STEM 20 X 200 MM IS IMPLANTED AFTER ATTACHING A PROXIMAL PART OF THE STEM 75 MM IN 10 DEGREES ANTEVERSION, TELESCOPING OF LESS THAN 1 MM IS EVIDENT. THE PROSTHESIS IS STABLE IN EXTENSION, EXTERNAL ROTATION AND FLEXION / INTERNAL ROTATION OF MORE THAN 60 DEGREES EACH, WHEREBY IN FULL HIP EXTENSION A KNEE FLEXION OF NO MORE THAN 70 TO 80 DEGREES IS POSSIBLE. THE LARGER DIAMETER OF THE NEW PROSTHESIS STEM PREVENTS ANATOMICAL REPOSITIONING OF THE FRAGMENTS OF THE PROXIMAL FEMUR. DURING THE REPOSITIONING ATTEMPTS, THE TROCHANTER FRAGMENTS BREAK SEVERAL TIMES, THEREFORE AN OSTEOSYNTHESIS WITH 4 CABLE CERCLAGES AND OSTEOSUTURES IS PERFORMED THROUGH THE HOLES IN THE PROXIMAL PART OF THE STEM. THE DEFECTS OF THE POSTERIOR CORTICAL BONE ARE FILLED WITH RESIDUAL BONE FROM THE DEBRIDEMENT. PRODUCT EVALUATION: VISUAL EXAMINATION: THE STEM, HEAD, INSERT AND SHELL WERE RECEIVED FOR INVESTIGATION. THE STEM SHOWS BONE ATTACHMENT IN THE ANCHORING REGION. AT THE DISTAL END OF THE TAPER A GROOVE CAN BE OBSERVED. THE GROOVE POINTS TO AN IMPINGEMENT. OTHER THAN THAT THE STEM TAPER IS INCONSPICUOUS. SOME SLIGHT SCRATCHES IN THE NECK AREA CAN ALSO BE OBSERVED. THE ARTICULATION SURFACE OF THE HEAD SHOWS NUMEROUS FINE SCRATCHES, SOME MILKY AREAS AS WELL AS SOME SMALLER AREAS WITH METALLIC SMEARING. THE HEAD TAPER IS INCONSPICUOUS. ON THE ARTICULATION SIDE, THE POLYETHYLENE RIM OF THE INSERT SHOWS SOME SCRATCHES. IN ONE AREA SIGNS OF LAYER DELAMINATION CAN BE OBSERVED. IN THIS AREA THE INLAY¿S BEVEL IS MATT AND SHOWS METALLIC MATERIAL TRANSFER. IN ONE AREA THE BEVEL IS WORN INDICATING RIM LOADING. ON THE ARTICULATION SURFACE NUMEROUS FINE SCRATCHES CAN BE SEEN. FURTHER, SHOWS SOME MATT AREAS WITH METALLIC SMEARING ARE VISIBLE. ALONG APPROX. HALF INLAY¿S BEVEL SOME COARSE SCRATCHES CAN BE OBSERVED (MOST LIKELY FROM THE REVISION SURGERY / INSTRUMENT). ON THE BACKSIDE OF THE INSERT THE POLE PIN OF THE INSERT IS SLIGHTLY DAMAGED AND DEFORMED. THE INDENTATIONS FROM THE FIXATION SPIKES ON THE SHELL CAN BE OBSERVED INDICATING A PROPER FIXATION OF THE INSERT IN THE SHELL. ON THE ANCHORING SIDE OF THE FITMORE SHELL THE SULMESH IS MISSING TO ABOUT 50%. THE REMAINING SULMESH DOES NOT SHOW ANY BONE ATTACHMENTS. THE REVEALING BACKSIDE OF THE SHELL IS PARTIALLY POLISHED AND SHOWS SOME SCRATCHES. THERE ARE IMPRINTS OF THE SULMESH AND SOME ADDITIONAL COARSER INDENTS PROBABLY DERIVING FROM SOME WIRE PIECES OF THE SULMESH. ADDITIONALLY, ONE OF THE ANCHORING FINS IS BROKEN OFF. THE INSIDE OF THE SHELL LOOKS INCONSPICUOUS. REVIEW OF PRODUCT DOCUMENTATION: DEVICE PURPOSE: THIS DEVICE IS INTENDED FOR TREATMENT. PRODUCT COMPATIBILITY: THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. DHR REVIEW: THE REVIEW SHOWED THAT ALL RELEASED PRODUCTS MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. CONCLUSION: IT WAS REPORTED THE PATIENT HAD THE INITIAL HIP SURGERY ON THE LEFT SIDE ON (B)(6) 2001. ON (B)(6) 2019 PATIENT HAD A REVISION SURGERY DUE TO A FALL, WHICH CAUSED A FRACTURE OF THE ACETABULAR TYPE B3 AS WELL AS A FRACTURE OF THE PROXIMAL FEMUR. ADDITIONALLY, PRE-SURGICAL BLOOD MEASUREMENT OF CO & CR SHOWED ELEVATED LEVELS. REVIEW OF THE MEDICAL DATA SHOWED RADIOLOGICAL INDICATIONS OF CUP LOOSENING SIX YEARS AFTER IMPLANTATION. 12 YEARS LATER ON (B)(6), RADIOLOGICALLY RECOGNIZABLE PROTRUSION OF THE CUP WITH A DEFECT IN THE ACETABULUM NEAR THE IMPLANT, THE SUSPICION OF A LARGER FEMORAL OSTEOLYSIS IN GREEN ZONE 1 AND 7 AND A DISLOCATED PERIPROSTHETIC DIAPHYSEAL FEMORAL SPIRAL FRACTURE AFTER A REPORTED FALL. MEDICAL REPORTS OR CLINICAL FINDINGS IN THE PERIOD BETWEEN THE PRIMARY IMPLANTATION AND THE PRESENT RADIOLOGICAL FOLLOW-UP ON (B)(6) 2007 AND ON (B)(6) 2019 ARE NOT AT HAND. FURTHER, THERE ARE NO CORRESPONDING LABORATORY REPORTS ON THE INCREASED METAL ION LEVELS FOR COBALT AND CHROMIUM IN THE BLOOD APPARENTLY REPORTED BEFORE THE FALL. ON (B)(6) 2019, THE PATIENT UNDERWENT THE REVISION SURGERY OF THE LEFT HIP. METALLOSIS IS DESCRIBED WHEN THE JOINT IS OPENED, INCLUDING A THICKENED CAPSULE INTERSPERSED WITH PRONOUNCED METALLOSIS ON THE JOINT SIDE. THE VISUAL EXAMINATION REVEALED AN IMPINGEMENT BETWEEN THE STEM AND THE SHELL. THIS IS CONSISTENT WITH THE OBSERVATION OF POSSIBLE RIM LOADING ON THE INSERT. THE SULMESH ON THE ANCHORING SIDE OF THE FITMORE SHELL IS MISSING TO ABOUT 50%. THE REMAINING SULMESH DOES NOT SHOW ANY BONE ATTACHMENTS. THIS IS CONSISTENT WITH THE LOOSENING REVEALED BY THE MEDICAL DOCUMENTATION. IT REMAINS UNKNOWN IN WHICH ORDER THE OBSERVATIONS OCCURRED AND HOW AND TO WHAT EXTENT THEY INFLUENCED EACH OTHER. BASED ON THE INVESTIGATION THE REPORTED EVENT CAN BE CONFIRMED. FURTHER, THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THEREFORE, THE INVESTIGATION DID NOT IDENTIFY A NONCONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). IT REMAINS UNKNOWN IF AND TO WHAT EXTEND THE OBSERVED IMPINGEMENT AND / OR POSSIBLE RIM LOADING MIGHT HAVE CONTRIBUTED TO THE REPORTED ELEVATED METAL ION LEVELS AS WELL AS THE DESCRIBED METALLOSIS. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THE REPORTED ELEVATED METAL IONS. AS ALREADY REPORTED THE BONE FRACTURE IS MOST LIKELY RELATED TO THE PATIENT'S FALL. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER SWITZERLAND MANUFACTURING GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2020-00195-1, 0009613350-2020-00197-1, 0009613350-2021-00051.

    Description of Event or Problem · 0

    INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    X-RAYS AND SURGICAL REPORTS WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. 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. (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED ON THE LEFT SIDE AND UNDERWENT REVISION DUE ACETABULAR FRACTURE, FRACTURE OF PROXIMAL FEMUR AND ELEVATED METAL IONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431959 METASUL HD 28MM L 12/14 N/A KWA ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 2041600

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R