BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FITMORE®, SHELL WITH SCREW CONES, UNCEMENTED, 48/GG

    MDR report key: 21809543 · Received April 9, 2025

    Report

    Report Number
    0009613350-2025-00279
    Event Type
    Injury
    Date Received
    April 9, 2025
    Date of Event
    March 19, 2025
    Report Date
    July 23, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10. TPP THRUST PLATE 38    12/14 ITEM# 0100161038 LOT# 2259551. METASUL®, ALPHA INSERT, GG/28 ITEM# 0100010407 LOT# 2277306. METASUL HEAD 28MM "M" 12/14 ITEM# 192806 LOT# 2279768. TPP LATERAL PLATE 15° ITEM# 0100161015 LOT# 2266984. TPP THREADED BOLT 81 ITEM# 0100161081 LOT# 2220079. CORTICAL SCREW A0 HD 36/4.5MM ITEM# 879 LOT# UNKNOWN. CORTICAL SCREW A0 HD 42/4.5MM ITEM# 882 LOT# UNKNOWN. G2. REPORT SOURCE: AUSTRALIA. 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 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, G6, H2, H6, H10, H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. DEVICES ARE USED FOR TREATMENT. SURGICAL RECORDS WERE NOT PROVIDED. HOWEVER, THE PRIMARY PROFORMA INCLUDING PRODUCT LABELS, REVISION USAGE AND JOINT REGISTRY FORM WERE PROVIDED. THE JOINT REGISTRY FORM STATES THAT THE INDICATION FOR REVISION SURGERY WAS PAIN. ONE AP X-RAY OF THE PELVIS WAS PROVIDED AND REVIEWED BY A RADIOLOGIST WITH THE FOLLOWING ASSESSMENT: "RIGHT HIP ARTHROPLASTY COMPONENTS ARE ANATOMICALLY ALIGNED. THERE IS NO FRACTURE OR DISLOCATION. THERE IS PROMINENT HETEROTOPIC OSSIFICATION ALONG THE LATERAL ASPECT OF THE HIP AND THERE IS A SMALL FOCUS OF OSTEOLYSIS IN GRUEN ZONE 1 OF THE FEMUR WITHOUT EVIDENCE OF IMPLANT LOOSENING. BONE QUALITY IS OSTEOPENIC. THE PROMINENT LATERAL HETEROTOPIC OSSIFICATION COULD RESULT IN PAIN AND LIMITED MOBILITY OF THE RIGHT HIP ARTHROPLASTY." HETEROTOPIC OSSIFICATION (HO) IS THE ABNORMAL AND RAPID GROWTH OF BONE THAT FORMS WITHIN SOFT TISSUE AS THE RESULT OF HEREDITY, TRAUMA, SURGICAL HISTORY, OR DISEASES OF A JOINT. THE RAPID AND IRREGULAR GROWTH OF BONE OFTEN CAUSES A SHARP OR JUTTED STRUCTURE TO FORM, WHICH CAN RESULT IN PAIN AND IRRITATION TO THE SURROUNDING TISSUES, OR THE PATIENT CAN REMAIN ASYMPTOMATIC. RADIATION OR NONSTEROIDAL ANTI-INFLAMMATORY MEDICATIONS ARE OFTEN PROVIDED TO PREVENT HO FORMATION. THE ONLY TREATMENT, IF NECESSARY, IS SURGICAL EXCISION OR SHAVING/SMOOTHING OUT THE EXCESS BONE. AS TIMEFRAMES OF ONSET DIFFER DUE TO INDIVIDUAL CONTRIBUTING FACTORS, A SPECIFIC TIMEFRAME OF EXPECTED OCCURRENCE CANNOT BE ESTABLISHED. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CAN BE CONFIRMED. AS PER ASSESSMENT OF THE PROVIDED X-RAY, IT IS STATED THAT "THE PROMINENT LATERAL HETEROTOPIC OSSIFICATION COULD RESULT IN PAIN AND LIMITED MOBILITY OF THE RIGHT HIP ARTHROPLASTY." HOWEVER, 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 THE PATIENT HAD A HIP REPLACEMENT. SUBSEQUENTLY, APPROXIMATELY 20 YEARS POST IMPLANTATION, UNDERWENT A REVISION SURGERY DUE TO PAIN. THRUST PLATE AND FITMORE SHELL WERE EXPLANTED. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    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
    1664408 FITMORE®, SHELL WITH SCREW CONES, UNCEMENTED, 48/GG IMPLANT, HIP. LZO ZIMMER GMBH 2269841

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention| H SEE H11 NARRATIVE.