BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 TYPE1 BM SO 10.0

    MDR report key: 21169407 · Received January 16, 2025

    Report

    Report Number
    0001825034-2025-00163
    Event Type
    Injury
    Date Received
    January 16, 2025
    Date of Event
    February 8, 2024
    Report Date
    February 26, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    UDI-DI
    00880304521490
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# 010000701, LOT# 7594141, G7 BONEMASTER LTD ACET SHL 48C. CAT# 650-1162, LOT# 3170550, DELTA CER FEM HD 32/0MM T1. G2: FOREIGN: COUNTRY: BELGIUM. 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.

    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 H6: COMPONENT CODE: MECHANICAL (G04) - STEM. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. INSUFFICIENT INFORMATION PROVIDED REGARDING THE COMPONENTS USED WITH THE STEM. UNABLE TO PERFORM A COMPATIBILITY CHECK FOR THE ENTIRE CONSTRUCT. A RADIOGRAPH WAS PROVIDED SHOWING A FEMUR WITH MULTIPLE FRACTURES; HOWEVER, THE IMAGE WAS NOT FURTHER REVIEWED AS ADDITIONAL INFORMATION WAS REQUIRED TO COMPARE INITIAL AND AFTER TRAUMA. A SECOND RADIOGRAPH WAS ALSO PROVIDED; HOWEVER, THE IMAGE WAS NOT DATED. FURTHER INFORMATION AND MEDICAL RECORDS WERE REQUESTED, BUT NO FURTHER RESPONSES WERE RECEIVED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE PROVIDED MEDICAL IMAGE, THE COMPLAINT OF MULTIPLE FRACTURE IS CONFIRMED. 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

    D10: CAT# 30123203 LOT# 65698879 G7 VIT E HIGH WALL LNR 32MM C. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS PUSHED THROUGH A REVOLVING DOOR WHICH RESULTED IN A LEFT BROKEN HIP. SUBSEQUENTLY, THE PATIENT HAD A LEFT TOTAL HIP ARTHROSCOPY ON AN UNKNOWN DATE. REPORTEDLY, DURING SURGERY, THE SURGEON BROKE 3 BONES, ONE OF WHICH WAS A PERIPROSTHETIC FRACTURE. THE PATIENT ALLEGED THAT NEITHER A PREOPERATIVE DEXA SCAN NOR A TEMPLATE WAS PERFORMED. APPROXIMATELY THREE MONTHS POST IMPLANTATION OF A LEFT TOTAL HIP ARTHROPLASTY, THE PATIENT WAS REVISED, AND THE PROSTHESIS WAS REMOVED. THE PATIENT REPORTS THAT SHE HAS NOT BEEN ABLE TO WALK TO THIS DAY, AND SUSPECTS THAT THE SURGEON BROKE THE BONES BECAUSE THE PROSTHESIS WAS A LITTLE BIGGER THAN HER HIP. THE PATIENT ALLEGED THAT THE SURGEON STITCHED THE PATIENT UP WITHOUT REALIZING THAT HE HAD BROKEN BONES. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY ONE YEAR AGO, AN INITIAL LEFT TOTAL HIP ARTHROPLASTY WAS COMPLETED AS SURGICAL MANAGEMENT FOLLOWING A FALL WITH FRACTURE. NO INTRA-OPERATIVE COMPLICATIONS OR EVENTS WERE NOTED. SUBSEQUENTLY ON POST-OP IMAGING THE NEXT DAY A PERIPROSTHETIC FRACTURE NEAR THE FEMORAL STEM WAS OBSERVED. CONSERVATIVE MANAGEMENT AND PROGRESSIVE REHABILITATION WERE ATTEMPTED HOWEVER, ULTIMATELY, DUE TO PAIN AND MOBILITY LIMITATIONS AS WELL AS CONCERN FOR NON-UNION AND POSSIBLE SUBSIDENCE REVISION WAS ADVISED. THE REVISION SURGERY WAS COMPLETED APPROXIMATELY 3 MONTHS AFTER THE INITIAL SURGERY, AND REPORTEDLY ALL ZIMMER BIOMET COMPONENTS WERE REMOVED. FURTHER DETAILS HAVE NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1510459 TPRLC 133 TYPE1 BM SO 10.0 PROTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 7682214 00880304521490

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H