BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASUL ALPHA INSERT, II/36

    MDR report key: 7368964 · Received March 26, 2018

    Report

    Report Number
    0009613350-2018-00376
    Event Type
    Injury
    Date Received
    March 26, 2018
    Date of Event
    February 28, 2018
    Report Date
    June 26, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    JDI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. 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: LUXATION. EVENT DESCRIPTION: LUXATION OF ALPHA INLAY IN ALLOFIT CUP. IMPLANTED: (B)(6) 2018, EXPLANTED: (B)(6) 2018. THE PATIENT HAS THA ON BOTH SIDES. WITH THE GIVEN INFORMATION, IT IS UNKNWON WHICH SIDE WAS COMPLAINED. BOTH SIDES ARE VERY SIMILAR. THE STEM IS DIFFERENT IN EACH SIDE. UNFORTUNATELY, THE STEM INFORMATION IS NOT GIVEN. NO MORE INFO IS AVAILABLE BECAUSE THE SURGEON DOES NOT WANT TO PROVIDE ANY FURTHER INFORMATION. REVIEW OF RECEIVED DATA: X-RAY PELVIC OVERVIEW WITHOUT DATE: RIGHT HIP JOINT CEMENTED SHAFT IN ORTHOGRADE POSITION. CUP IS CEMENTLESS, ANTEVERSION NOT RELIABLY ASSESSABLE, INCLINATION ANGLE APPROX. 43 °. NO DETECTABLE OSTEOLYSIS, NO EVIDENCE OF LOOSENING OF THE IMPLANT COMPONENTS ON THE RIGHT. LEFT HIP JOINT WITH CEMENTLESS ORTHOGRADE INSET SHAFT WITHOUT LOOSENING MARKS. NON-CEMENTED CUP, ANTEVERSION NOT RELIABLY ASSESSABLE, INCLINATION ANGLE APPROX. 46 °. THE GREATER TROCHANTER APPEARS IN TWO PARTS AS IN THE POST-FRACTURED CONDITION WITH DISSEMINATED INTRAOSSEOUS WHITENING. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: NO PRODUCT DOCUMENTATION WAS REVIEWED FOR INVESTIGATION. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING RMW (ALLOFT-S ALLOCLASSIC SHL 52/II): 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 AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION. IMPLANT DISLOCATION / LOOSENING / BREAKAGE / IMPINGEMENT DUE TO INCORRECT POSITION REGARDING CUP INCLINATION AND ANTEVERSION NOT POSSIBLE THE PROVIDED X-RAY DO NOT SHOW AMY ABNORMALITY. IMPLANT DISLOCATION / LOOSENING DUE TO INCORRECT SCREW BORE DIRECTION. POSSIBLE, NO INFORMATION RECEIVED ABOUT IMPLANTATION. NO SURGICAL REPORT RECEIVED. IMPLANT DISLOCATION / LOOSENING DUE TO INCORRECT SCREW INSERTION. POSSIBLE, NO INFORMATION RECEIVED ABOUT IMPLANTATION. NO SURGICAL REPORT RECEIVED. IMPLANT DISLOCATION / LOOSENING DUE TO LACK OF INSERTION FORCE. POSSIBLE, NO INFORMATION RECEIVED ABOUT IMPLANTATION. NO SURGICAL REPORT RECEIVED. IMPLANT DISLOCATION / LOOSENING DUE TO LACK OF ADEQUATE INSERTION FORCE. POSSIBLE, NO INFORMATION RECEIVED ABOUT IMPLANTATION. NO SURGICAL REPORT RECEIVED. IMPLANT DISLOCATION / LOOSENING DUE TO INAPPROPRIATE INFORMATION ON PACKAGING LABEL OR NOT LEGIBLE PACKAGING LABEL LEADS TO INCORRECT/OFF-LABEL USE OF IMPLANT. NOT POSSIBLE -> NO ISSUE REPORTED REGARDING PACKAGING LABEL. CONCLUSION SUMMARY: IT WAS REPORTED THAT THE ALPHA INLAY IN THE ALLOFIT CUP WAS LUXATED. IMPLANTED: (B)(6) 2018, EXPLANTED: (B)(6) 2018. THE PATIENT HAS THA ON BOTH SIDES. WITH THE GIVEN INFORMATION, IT IS UNKNWON WHICH SIDE WAS COMPLAINED. AN UNDATED X-RAY WAS RECEIVED WHICH SHOWS THE PELVIC OVERVIEW. THE X-RAY WAS REVIEWED BY AN INDEPENDENT HEALTHCARE PROFESSIONAL. THE RIGHT SIDE SHOWS NO SIGNS OF LOOSENING AND NO OSTEOLYSIS THE INCLINATION ANGLE IS 43°. THE LEFT SIDE SHOWS THAT THE GREATER TROCHANTER APPEARS IN TWO PARTS AS IN THE POST-FRACTURED CONDITION WITH DISSEMINATED INTRAOSSEOUS WHITENING. NO SIGNS OF STEM LOOSENING. THE INCLINATION ANGLE IS 46. NO DEVICES WERE RETURNED FOR MATERIAL ANALYSIS, THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. BOTH SIDES SHOW NO ABNORMALITY. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC 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). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2018-00373-1.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: COCR HEAD 36/-4 'S' 12/14 CATALOG #: 0101012365 ; LOT #: 2921178, ALLOFT-S ALLOCLASSIC SHL 52/II CATALOG #: 00000004265 ; LOT #: 2927826. THERAPY DATE : (B)(6) 2018. THE MANUFACTURER DID NOT RECEIVE 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. 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 SURGERY DUE TO LUXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214320 DURASUL ALPHA INSERT, II/36 DURASUL ALPHA INSERT JDI ZIMMER GMBH N/A 2884240

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R