BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CUP

    MDR report key: 18730947 · Received February 19, 2024

    Report

    Report Number
    0001825034-2024-00400
    Event Type
    Injury
    Date Received
    February 19, 2024
    Date of Event
    December 20, 2023
    Report Date
    February 21, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    NI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN: AUSTRALIA. D10: CAT# 11-300915 LOT# 977420 ARCOS ST DIST STEM TI 15X190 BI, CAT# 11-301332 LOT# 556460 ARCOS CONE HIGH BODY TI PC 70, CAT# 11-363663 LOT# 553440 36MM COCR MOD HD +3MM, CAT# UNK LOT# UNK UNKNOWN LINER, CAT# 00223200418 LOT# UNK CABLE READY GTR COCR CABLE, CAT# 00223200418 LOT# 65228591 CABLE READY GTR COCR CABLE, CAT# 00223200418 LOT# 65232761 CABLE READY GTR COCR CABLE, CAT# 00223200418 LOT# 65232765 CABLE READY GTR COCR CABLE, CAT# 00223200418 LOT# 65240290 CABLE READY GTR COCR CABLE , CAT# 00236901435 LOT# UNK 3.5MMX14MM TI LOCKING SCREW , CAT# 00236903835 LOT# UNK 3.5MMX14MM TI LOCKING SCREW, CAT# 00236904435 LOT# UNK 3.5MMX14MM TI LOCKING SCREW, CAT# 47-9986-021-26 LOT# 56715038 LONG OST BLADE 10MMX5, CAT# 00236901635 LOT# UNK 5MMX16MM TI LOCKING SCREW, CAT# 00236902235 LOT# UNK 5MMX16MM TI LOCKING SCREW, CAT# 00236903035 LOT# UNK 5MMX16MM TI LOCKING SCREW, CAT# 02.02150.300 LOT# 3034939 NCB CLAMP-SCREW, CAT# 02.02150.300 LOT# 3059655 NCB CLAMP-SCREW, CAT# 02.02150.300 LOT# UNK NCB CLAMP-SCREW , CAT# 02.02263.000 LOT# 2934192 NCB PP PF PLATE, SHORT, RIGHT, L115, CAT# 02.02263.201 LOT# 3028988 NCB PP TROC PLATE, RIGHT, NARROW G, CAT# 02.03150.042 LOT# UNK NCB SCREW 5.0 L=42 , CAT# 02.03151.016 LOT# UNK NCB UNICORTICAL SCR 5.0 L=16M , CAT# 02.03151.018 LOT# UNK NCB UNICORTICAL SCR 5.0 L=18M, CAT# 02.03151.020 LOT# UNK NCB UNICORTICAL SCR 5.0 L=20M, CAT# 290.20.280 LOT# UNK KIRSCHNER WIRE L280. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2024-00399, 0001825034-2024-00401, 0001825034-2024-00403, 0001825034-2024-00436.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4;G3;H2;H3;H6 NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: SIZING OF THE IMPLANT WAS APPROPRIATE. ACETABULI PROTRUSIO OF THE CUP. POSSIBLE SUPERIOR MIGRATION OF A LATERAL FEMORAL PLATE AND SCREW FIXATION DEVICE NOW PERCHED ALONG THE ANTERIOR SUPERIOR ILIAC SPINE. INSUFFICIENT INFORMATION PROVIDED, AS PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS AND COMPATIBILITY CHECKS, AND NEITHER WERE PROVIDED FOR THE LINER AND SHELL COMPONENTS. DURING THE INVESTIGATION PROCESS THE STERILE CERTIFICATIONS WERE NOT REVIEWED, AS NO PRODUCT PART/LOT INFORMATION WAS PROVIDED. ALL DEVICES MANUFACTURED FOLLOW ACCEPTABLE STERILIZATION PROCESSES ACCORDING TO PUBLISHED ISO/AAMI/ASTM & EU GUIDELINES. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN INFECTION THAT ARE OUTSIDE THE CONTROL OF ZIMMER BIOMET, SUCH AS EXTERNAL FACTORS, I.E. HOSPITAL/SURGICAL ENVIRONMENT, PROVIDER RELATED RISK FACTORS, AND/OR PATIENT COMORBIDITIES/RISK FACTORS. ALL PRODUCTS MANUFACTURED FOLLOW APPROPRIATE STANDARDS, AND THE REPORTED INFECTION OCCURRED > 90 DAYS; THEREFORE, IMPLANTED PRODUCTS ARE NOT IDENTIFIED AS THE SOURCE OR CONTRIBUTING TO THE REPORTED INFECTION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 21 MONTHS POST IMPLANTATION OF A RIGHT TOTAL HIP ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO THE CUP MIGRATING MEDIALLY, A LOOSE STEM, AND AN INFECTION. NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542496 UNKNOWN CUP PROTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R