BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLOCLASSIC SL STEM 3 12/14

    MDR report key: 7845226 · Received September 5, 2018

    Report

    Report Number
    0009613350-2018-00991
    Event Type
    Injury
    Date Received
    September 5, 2018
    Date of Event
    August 17, 2018
    Report Date
    May 23, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    PK030373
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE PREVIOUS MEDWATCH. ADDITIONAL AND CORRECTED INFORMATION ARE FILLED IN THE FOLLOWING FIELDS: 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 · 0

    CONCOMITANT MEDICAL PRODUCTS ACCORDING D11: ITEM: METASUL INSERT JJ/28 CATALOG #: 4346 LOT #: 2087289 ITEM: ALLOFIT ALLOCLASSIC SHL 54/JJ CATALOG #: 4246 LOT #: 2023405 ITEM: METASUL HEAD 28MM "M" 12/14 CATALOG #: 192806 LOT #: 2074995 DHR-REVIEW: REF:(B)(4). LOT:2082479 - YIELD:100 - DELIVERED:100 THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. REF:(B)(4). LOT:2087289 - YIELD:43 - DELIVERED:43 THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. REF:(B)(4). LOT:2023405 - YIELD:50 - DELIVERED:50 THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. REF:(B)(4). LOT:2074995 - YIELD:70 - DELIVERED:70 THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. EVENT DESCRIPTION: IT WAS REPORTED THAT THE PRODUCT WAS IMPLANTED ON (B)(6) 2001 AND REVISED ON (B)(6) 2018 DUE TO BONE FRACTURE. REVIEW OF RECEIVED DATA: - RIGHT HIP AP-VIEW (PHOTOGRAPHED X-RAY): PERIPROSTHETIC FRACTURE WITH A LARGE TROCHANTER MAJOR FRAGMENT, META-/DIAPHYSEAL FRAGMENT MEDIAL, FRACTURE OF THE TROCHANTER MINOR AND AND TIPPING THE TROCHANTER MINOR MEDIALLY. THE CEMENTLESS PROSTHESIS STEM IS TILTED ABOUT 19 DEGREES IN VARUS. SELF-CREATED SPOT VIEW PROXIMAL: CYSTIC-CONFLUENT BRIGHTENINGS OF THE OSSEOUS STRUCTURE IN THE AREA OF THE TROCHANTER MAJOR. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION. ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. - THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING RMW: - IMPLANT BREAKAGE, BONE FRACTURE DUE TO WRONG PLANNING TEMPLATE USED MISINTERPRETATION OF THE X-RAY TEMPLATES REGARDING CENTER OF ROTATION/LEG LENGTH/OFFSET. POSSIBLE, AS THERE ARE NO X-RAYS AVAILABLE RIGHT AFTER THE IMPLANTATION. THE IMPLANT POSITION AFTER THE IMPLANTATION IS UNKNOWN. THEREFORE, THIS POINT CANNOT BE EXCLUDED. EXCESSIVE LOAD APPLIED TO THE BONE DUE TO EXCESSIVE IMPACTION FORCE. NOT POSSIBLE, AS THE IMPLANTS WERE IN VIVO FOR APPROX. 17 YEARS. AN EXCESSIVE LOAD APPLIED TO THE BONE WOULD HAVE BEEN DETECTED EARLIER. EXCESSIVE LOAD APPLIED TO THE BONE DUE TO WRONG HANDLING OF INSTRUMENTATION OR EXCESSIVE FORCE REQUIRED TO EXTRACT STEM. NOT POSSIBLE, AS THE IMPLANTS WERE IN VIVO FOR APPROX. 17 YEARS. AN EXCESSIVE FORCE TO THE BONE WOULD HAVE BEEN DETECTED EARLIER. CONCLUSION SUMMARY: APPROXIMATELY 17 YEARS AFTER RIGHT SIDED CEMENTLESS HIP REPLACEMENT, A REVISION DUE TO A FRACTURE IS REPORTED ON (B)(6) 2018. AT THE TIME OF REPORTING, A NORMAL-WEIGHT OF A 84-YEAR-OLD FEMALE PATIENT IS MENTIONED. A PERIPROSTHETIC FEMORAL FRACTURE CAN BE SEEN ON AN UNDATED, PHOTOGRAPHED RIGHT HIP X-RAY IN THE AP-VIEW. IT SHOWS A VARUS DEVIATION OF THE STEM OF ABOUT 19 DEGREES.THE FEMUR IS FRACTURED METAPHYSEAL-DIAPHYSEAL, A LARGE TROCHANTER MAJOR FRAGMENT, FRACTURE OF THE LESSER TROCHANTER WITH MEDIAL TILTING AND CYSTIC-CONFLUENT OSSEOUS BRIGHTENINGS IN THE AREA OF THE TROCHANTER MAJOR. HOWEVER, BASED ON THE AVAILABLE INFORMATION, AN EXACT ROOT CAUSE FOR THE BONE FRACTURE COULD NOT BE DETERMINED. 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). .

    Description of Event or Problem · 0

    INVESTIGATION RESULTS ARE NOW AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER RECEIVED X-RAYS AND OTHER SOURCE DOCUMENTS 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689379 ALLOCLASSIC SL STEM 3 12/14 ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM LZO ZIMMER GMBH N/A 2082479

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R