BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX® OPTION, HEAD, M, ø 40/0, TAPER 12/14

    MDR report key: 25248523 · Received May 21, 2026

    Report

    Report Number
    0009613350-2026-00264
    Event Type
    Injury
    Date Received
    May 21, 2026
    Date of Event
    October 19, 2022
    Report Date
    May 21, 2026
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    UDI-DI
    00889024430563
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10.G7 OSSEOTI MULTIHOLE 56MM F ITEM# 110010266 LOT# 6982870. BONE SCREW SELF-TAPPING 6.5 MM DIA. 25 MM LENGTH ITEM# 00625006525 LOT# 64894184. BONE SCREW SELF-TAPPING 6.5 MM DIA. 20 MM LENGTH ITEM# 00625006520 LOT# 63913605. BONE SCREW SELF-TAPPING 6.5 MM DIA. 50 MM LENGTH ITEM# 00625006550 LOT# 63913605. G7 HI-WALL E1 LINER 40MM F ITEM# 010000942 LOT# 8807035. G2: FOREIGN - EVENT OCCURRED IN ITALY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE AN INITIAL LEFT TOTAL HIP ARTHROPLASTY APPROXIMATELY 12 YEARS EARLIER. AROUND MID-2021, THE PATIENT ACCIDENTALLY FELL AND SUSTAINED A SMALL FRACTURE TO THE ACETABULAR FLOOR BENEATH THE CUP. A FEW MONTHS LATER, RADIOGRAPHIC IMAGING DISPLAYED SINKING OF THE CUP WITH EVIDENT BONE DEFICIT AT THE ACETABULAR ROOF, AND SERUM COBALT AND CHROMIUM LEVELS WERE ELEVATED. SEVERAL MONTHS LATER, THE PATIENT UNDERWENT AN ACETABULAR REVISION AND REACTIVE GRAY SYNOVITIS OF A METALLOSIS TYPE AT THE STEM AND ACETABULUM, TRUNNIONOSIS, AND ABSENCE OF THE ANTERIOR WALL WITH EXTENSIVE ACETABULAR OSTEOLYSIS WERE FOUND. THE FRACTURED BONE FRAGMENT WAS SYNTHESIZED WITH TWO CORTICAL SCREWS AND ALL OTHER COMPONENTS WERE REVISED EXCEPT FOR THE STEM. POST-OPERATIVELY, THE PATIENT¿S HEMOGLOBIN DROPPED TO 7.6 G/DL AND REQUIRED ONE UNIT OF TRANSFUSED RED BLOOD CELLS. THE PATIENT WAS UNDERGOING A SLOW PROGRESSIVE RECOVERY AND, SEVERAL MONTHS LATER, AFTER A SHORT WALK WITH WEIGHT BEARING, HAD AN ONSET OF PAIN. RADIOGRAPHIC IMAGING DISPLAYED A PERIPROSTHETIC FLUID COLLECTION, RESORPTION OF THE GRAFT, AND CUP PROTRUSION, AND SUBSEQUENTLY THE PATIENT UNDERWENT AN ULTRASOUND-GUIDED ASPIRATION. ABOUT A WEEK LATER, THE PATIENT PRESENTED TO THE EMERGENCY ROOM AND WAS ADMITTED TO THE HOSPITAL WITH HIP PAIN, ANEMIA, AND HEMATOMA WITHIN THE ILIOPSOAS MUSCLE, AND REQUIRED BLOOD TRANSFUSIONS DURING THE HOSPITALIZATION. LATER THAT MONTH, THE PATIENT UNDERWENT A REVISION WHERE A LARGE HEMATOMA WAS EVACUATED, THE CUP HAD MIGRATED AND WAS FOUND WITHOUT SIGNS OF OSTEOINTEGRATION, AND THERE WAS ABSENCE OF THE ANTERIOR WALL AND ACETABULAR FLOOR. DURING THE PROCEDURE, AN EXPECTED VENOUS BLEED FROM THE ACETABULAR FLOOR WAS ENCOUNTERED AND CORRECTED BY A VASCULAR SURGEON. DUE TO THE BLOOD LOSS, THE PATIENT REQUIRED INTRA-OPERATIVE AND POST-OPERATIVE BLOOD TRANSFUSIONS FOR HEMODYNAMIC STABILITY. ALL IMPLANTS, EXCEPT THE STEM, WERE REVISED. FOLLOWING THE SURGERY, THE PATIENT REMAINED INTUBATED IN THE ICU FOR A TOTAL OF THREE DAYS AND THEN UNDERWENT AN UNEVENTFUL POST-OPERATIVE RECOVERY AND WAS DISCHARGED HOME. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148747 BIOLOX® OPTION, HEAD, M, ø 40/0, TAPER 12/14 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LZO ZIMMER GMBH 3085487 00889024430563

    Patients

    Seq Age Sex Outcome Treatment
    1