BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METASUL HEAD 28MM M 12/14

    MDR report key: 9303192 · Received November 11, 2019

    Report

    Report Number
    0009613350-2019-00667
    Event Type
    Injury
    Date Received
    November 11, 2019
    Date of Event
    March 18, 2019
    Report Date
    February 10, 2020
    Manufacturer
    ZIMMER 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY INVESTIGATION RESULT. DHR REVIEW: THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO ADDITIONAL SIMILAR INVESTIGATED EVENTS. EVENT DESCRIPTION: USER REPORT RECEIVED STATES DECENTRALIZATION OF THE INLAY WHICH WAS IMPLANTED IN PRIMARY IMPLANTATION SURGERY ON (B)(6) 2003 AND REVISED ON (B)(6) 2019. INTRAOPERATIVELY ROTATION INSTABILITY OF THE METASUL INLAY FOR ACA-SOCKET 48MM AGAINST THE POLYTHENE AND LOOSENING. MOREOVER, INLAY WEAR IS MENTIONED. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICE 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. 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: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED ON (B)(6) 2003 WITH A TOTAL HIP PROSTHESES: HEAD AND INLAY WERE REVISED ON (B)(6) 2019 DUE TO DECENTRALIZATION OF THE INLAY AND INLAY WEAR. INTRAOPERATIVELY ROTATION INSTABILITY OF METASUL AGAINST POLYETHYLENE AND LOOSENING HAVE BEEN DETECTED. 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. NEITHER X-RAYS, OPERATIVE NOTES, OFFICE VISIT NOTES, NOR DEVICES OR PHOTOS OF THE EXPLANTED IMPLANTS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. MOREOVER THE CORRECT IMPLANT POSITIONING (E.G. INCLINATION ANGLE OF THE CUP) REMAIN UNKNOWN. BASED ON THE AVAILABLE 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).

    Description of Event or Problem · 0

    PLEASE REFER TO REPORT 0009613350-2019-00667.

    Additional Manufacturer Narrative · 1

    MEDICAL PRODUCTS AND THERAPY DATE DETAIL OF PRODUCT: ITEM NUMBER 0100010407, ITEM NAME METASUL, ALPHA INSERT, GG/28, LOT # 2176722. ITEM NUMBER 4090140, ITEM NAME ACA ANCHORAGE CAP 48/GG, LOT # 2152082. ITEM NUMBER 0100063013, ITEM NAME OPTAN, STEM, RIGHT, UNCEMENTED, 13, TAPER 12/14, LOT # 2171124. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR 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. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS 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

    IT WAS REPORTED THAT THERE WAS INTRAOPERATIVE ROTATION-INSTABILITY OF METASUL-INLAY COMPARED TO POLYETHYLEN AND LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097882 METASUL HEAD 28MM M 12/14 N/A KWA ZIMMER GMBH N/A 2176398

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R