BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMUR SCREW STD 18MM

    MDR report key: 14546912 · Received May 31, 2022

    Report

    Report Number
    0001822565-2022-01622
    Event Type
    Injury
    Date Received
    May 31, 2022
    Date of Event
    May 3, 2022
    Report Date
    June 2, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    OLO
    PMA / PMN Number
    NI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORT SOURCE: (B)(6). CONCOMITANT PRODUCTS: UNKNOWN-UNKNOWN INTELLIJOINT-UNKNOWN ; 000-0212- CAMERA DRAPE-UNKNOWN ; 000-0163- PELVIC SCREW STD 116MM-UNKNOWN ; 010000702- G7 BONEMASTER LTD ACET SHL 50D- 6938039; 010000856- G7 NEUTRAL E1 LINER 36MM D- 6782814; 51-113100- TPRLC 133 TYPE1 BM SO 10.0- 6987844; 11-363662- 36MM COCR MOD HD STD- 680410; MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2022 - 01581. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, PRODUCT LOCATION UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B5; G3; H2 UPON REVIEW, IT WAS DETERMINED THAT WE DO NOT HAVE REPORTING RESPONSIBILITY FOR THIS HIP SYSTEM. THE INITIAL REPORT WAS SUBMITTED IN ERROR RAND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED AFTER USING THE INTELLIJOINT FOR A HIP REPLACEMENT THE PATIENT EXPERIENCED A FRACTURE OF THE GREATER TROCHANTER. THE SURGEON BELIEVES THAT THE PLATFORM IN COMBINATION WITH THE FEMORAL SCREW CREATED A STRESS RISER THAT CAUSED THE FRACTURE. FRACTURE IS DISPLACED AND CONTAINED WITHIN THE SOFT TISSUE SO DOESN¿T REQUIRE FURTHER INTERVENTION AT THIS STAGE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    UPON REVIEW, IT WAS DETERMINED THAT WE DO NOT HAVE REPORTING RESPONSIBILITY FOR THIS HIP SYSTEM. THE INITIAL REPORT WAS SUBMITTED IN ERROR RAND SHOULD BE VOIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1599117 FEMUR SCREW STD 18MM PROSTHESIS, HIP OLO ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other