BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVENIR CMPL HA HO NC SIZE 6

    MDR report key: 18334468 · Received December 15, 2023

    Report

    Report Number
    0001822565-2023-03645
    Event Type
    Injury
    Date Received
    December 15, 2023
    Date of Event
    August 25, 2023
    Report Date
    December 14, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    UDI-DI
    00889024508798
    PMA / PMN Number
    K182048
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 00877503602 BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 36/0, TAPER 12/14 UNKNOWN 010000703 G7 BONEMASTER LTD ACET SHL 52E 7500034 30103605 36MM I.D. SIZE E NEUTRAL LINER 65619431 G2: FOREIGN: BELGIUM NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: INITIAL ANATOMIC ALIGNMENT OF THE RIGHT HIP ARTHROPLASTY COMPLICATED BY A NON-DISPLACED PERIPROSTHETIC FRACTURE OF THE FEMUR WITH SUBSEQUENT IMPLANT SUBSIDENCE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT WAS CONFIRMED BASED ON THE PROVIDED X-RAYS. 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 THE PATIENT WAS DIAGNOSED WITH PERI PROSTHETIC FRACTURE. THE PATIENT WAS HAVING MORE THAN NORMAL PAIN AT REHABILITATION. THERE WAS NO TRAUMA OR SUDDEN PAIN REPORTED. PATIENT HAD A CT SCAN THAT REVEALED A FEMORAL FISSURATION WITH A 2-3MM SUBSIDENCE OF THE STEM COMPARED TO THE DIRECT POST OP RADIOGRAPH. A CERCLAGE OF THE FEMUR WAS PERFORMED, AND ALL IMPLANTS MAINTAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885940 AVENIR CMPL HA HO NC SIZE 6 PROTHESIS, HIPS LZO ZIMMER BIOMET, INC. N/A 3149381 00889024508798

    Patients

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