BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZCA ALL-POLY ACETABULAR CUP

    MDR report key: 16894213 · Received May 9, 2023

    Report

    Report Number
    0001822565-2023-01237
    Event Type
    Injury
    Date Received
    May 9, 2023
    Date of Event
    April 18, 2023
    Report Date
    August 11, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K191449
    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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4, B5, G3, H2, H3, H6 THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. VISUAL EXAMINATION OF THE PROVIDED PICTURE IDENTIFIED THAT THE ZCA CUP WAS EXPLANTED AND COVERED IN BIO-DEBRIS. THE LOCKING RING WAS NOTED TO BE BENT AND DEFORMED. NO FURTHER EVALUATION COULD BE MADE FROM THE PROVIDED PICTURE. RADIOGRAPHS WERE ALSO PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL. THE AVAILABLE RECORDS IDENTIFIED THAT THE PATIENT HAD A LEFT TOTAL HIP ARTHROPLASTY WITH SIGNIFICANT AMOUNT OF CEMENT NOTED ALONG THE ACETABULAR CUP, AS WELL AS POSSIBLE DISLOCATION OF THE RADIOLUCENT POLYETHYLENE LINER. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY AND IT WAS DETERMINED THAT THE ZCA CUP IS NOT INTENDED TO BE CEMENTED INTO THE ACETABULAR SHELL. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO USER ERROR, AS THE SURGEON HAD CEMENTED THE ZCA CUP INTO A SHELL WITHIN THE ACETABULUM. PER THE DEVICE IFU FOR CUPS AND LINERS, THE DEVICES SHOULD NOT BE USED FOR OTHER THAN LABELED INDICATIONS. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 802203202 ¿ COCR HEAD ¿ 3082691. 00811400110 ¿ CPT STEM ¿ 64363028. G2: REPORT SOURCE AUSTRALIA. PRODUCT WILL NOT BE RETURNING TO ZIMMER BIOMET FOR THE INVESTIGATION AS THE PRODUCT LOCATION IS UNKNOWN. 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: 0001822565 - 2023 - 01236

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION TO REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 2 MONTHS POST IMPLANTATION DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1954258 ZCA ALL-POLY ACETABULAR CUP PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 64210823

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H SEE H10