BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK CPT FEMORAL STEM

    MDR report key: 23495202 · Received November 7, 2025

    Report

    Report Number
    0001822565-2025-04023
    Event Type
    Injury
    Date Received
    November 7, 2025
    Date of Event
    April 13, 2025
    Report Date
    January 13, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4, B5, G3, G6, H2, H6, H11. D4: ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. THE REPORTED EVENT COULD NOT BE CONFIRMED DUE TO LACK OF PRODUCT/INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS NOT REVIEWED DUE TO LACK OF PRODUCT IDENTIFICATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN: AUSTRALIA. SUGGESTED COMPONENT CODE- MECHANICAL (G04): STEM. CUSTOMER HAS INDICATED THAT THE 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. REFERENCE: THOMAS S. ROBERTSON, MBBS, LUCIAN B. SOLOMON, MD, PHD, FRACS, DONALD W. HOWIE, MBBS, PHD, FRACS, OKSANA T. HOLUBOWYCZ, PHD, CHAN HEE CHO, BHMS HONS, STUART A. CALLARY, BAPPSC, PHD, (2025). HIGHLY POROUS TANTALUM ACETABULAR COMPONENTS WITHOUT ANCILLARY SCREWS ARE NON-INFERIOR AT 7 YEARS WHEN COMPARED WITH TITANIUM COMPONENTS WITH ANCILLARY SCREW FIXATION: A RANDOMIZED CONTROLLED TRIAL. ARTHROPLASTY TODAY, 33 (101709) HTTP://DX.DOI.ORG/XX.XXX/YYYYY.

    Description of Event or Problem · 0

    ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE WAS OBTAINED ON THAT THE PURPOSE OF THE STUDY WAS TO DETERMINE IF THE MID-TERM MIGRATION OF TANTALUM ACETABULAR COMPONENTS WITHOUT ANCILLARY SCREW FIXATION IS NO GREATER THAN THAT OF FIBER METAL TITANIUM COMPONENTS WITH ONE ANCILLARY SCREW FIXATION. THE STUDY REVIEWED 66 PRIMARY THA PATIENTS, DUE TO A DIAGNOSIS OF PRIMARY OR SECONDARY OA, OF WHOM 51 WERE AVAILABLE AT 7-YEAR FOLLOW-UP. ALL PROCEDURES WERE UNDERTAKEN AT THE ROYAL ADELAIDE HOSPITAL AND WERE PERFORMED BY ONE OF SIX ATTENDING SURGEONS OR RESIDENTS/FELLOWS UNDER THEIR SUPERVISION. THE PATIENTS WERE RANDOMIZED TO RECEIVE EITHER A TANTALUM OR TITANIUM ACETABULAR COMPONENT. ALL ARTHROPLASTIES WERE UNDERTAKEN USING A CEMENTED POLISHED FEMORAL STEM WITH A 12/14 TAPER (CPT; ZIMMER, WARSAW, IN), A COBALT CHROMIUM 28-MM FEMORAL HEAD (VERSYS; ZIMMER), AND AN UNCEMENTED MODULAR ACETABULAR COMPONENT COMPRISING A 10 ELEVATED HIGHLY CROSS-LINKED POLYETHYLENE LINER (LONGEVITY; ZIMMER) IN EITHER A CEMENTLESS PRESS-FIT SOLID-BACKED TANTALUM ACETABULAR SHELL (TRABECULAR METAL; ZIMMER) WITH NO SCREW FIXATION OR A CEMENTLESS PRESS-FIT CLUSTER-HOLED TITANIUM FIBRE-METAL ACETABULAR SHELL FIXED WITH ONE SCREW (TRILOGY; ZIMMER). NINE TANTALUM BEADS (1.0-MM DIAMETER, RSA BIOMEDICAL, UMEA, SWEDEN) WERE INSERTED INTRA-OPERATIVELY INTO THE PERIPROSTHETIC ACETABULAR BONE OF EACH PATIENT. ALL PATIENTS IN THIS TRIAL WERE BETWEEN THE AGES OF 40-64 YEARS AT THE TIME OF PRIMARY THA. RADIOGRAPHIC FOLLOW-UP TO ASSESS MIGRATION WAS CONDUCTED AT 4-6 DAYS POST-OP, 6 WEEKS, 3 MONTHS, 1, 2, 3, 5, AND 7 YEARS AFTER SURGERY. THE STUDY REPORTED 2 PATIENTS WITHIN THE TITANIUM CUP GROUP HAD ORIF DUE TO FEMORAL PERIPROSTHETIC FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171047 UNK CPT FEMORAL STEM PROSTHESIS, HIPS LZO ZIMMER BIOMET, INC. N/A UNK

    Patients

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