BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCR SELF-TAP

    MDR report key: 13976583 · Received April 1, 2022

    Report

    Report Number
    0001822565-2022-00947
    Event Type
    Injury
    Date Received
    April 1, 2022
    Date of Event
    March 3, 2022
    Report Date
    May 26, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K934765
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ITEM#:00625006530, LOT#:J6925767. OR ITEM#: 00625006525, LOT#: J7021980. CONCOMITANT MEDICAL PRODUCTS: 010000662 G7 SHELL 50D 7085818; 00877503601 BIOLOXÂ CERAMIC HEAD 3081675; 00771100600 FEMORAL STEM 12/14 65059818; 00625006530 BONE SCR 6.5X30 SELF-TAP J6925767; 00625006525 BONE SCR 6.5X25 SELF-TAP J7021980; 00625006525 BONE SCR 6.5X25 SELF-TAP J7021980; 010000856 G7 NEUTRAL E1 LINER 36MM D 6984458. FOREIGN: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 0001825034-2022-00684.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D4: LOT#J6925767; EXPIRATION DATE: 12/14/2030; MANUFACTURING DATE: 12/15/2020; UDI:(B)(4). LOT#J7021980; EXPIRATION DATE: 05/19/2031; MANUFACTURING DATE: 05/20/2021; UDI: (B)(4). REPORTED EVENT WAS CONFIRMED DUE TO THE REVIEW OF MEDICAL RECORDS AND PHOTOS. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE SCREWS TO SHOW SOME BURRS AND DAMAGE AROUND THE HEX ON THE HEAD OF THE SCREW. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED FINDINGS OF THE REPORTED ISSUES: LEFT TOTAL HIP ARTHROPLASTY WITH LOOSENING OF THE ACETABULAR CUP WITH ONE OF THE SCREWS COMPLETELY WITHIN THE BONE AND NOT SEEN INVOLVING THE ACETABULAR CUP. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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 ON THE POSTOPERATIVE X-RAY OF AN INITIAL TOTAL HIP REPLACEMENT, IT WAS FOUND THAT THE SCREW WAS OUTSIDE OF THE CUP, AND THE CUP DID NOT SEEM TO BE FULLY ATTACHED TO THE ACETABULAR. FOLLOWED PROPER TECHNIQUE, USED TRILOGY SCREW, WITH G7 SPECIFIC GOLDEN DRILL GUIDE AND DRILL SHAFT. SAME DAY RE-OPENED AND REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710431 BONE SCR SELF-TAP PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A SEE H10

    Patients

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