BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERAMIC RNGLC ACET LINER 23/28

    MDR report key: 22993042 · Received September 8, 2025

    Report

    Report Number
    0001825034-2025-02826
    Event Type
    Injury
    Date Received
    September 8, 2025
    Date of Event
    August 13, 2025
    Report Date
    November 20, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) D10: HAP MALLORY/HEAD ACETABULAR SHELL 50MM ITEM: 103580, LOT: 229705. (COMPETITOR PRODUCTS) J&J S-ROM FEMORAL STEM 18X13X160 ITEM: 52-3193, LOT: 1106543. DEPUY S-ROM BIOLOX FORTE CERAMIC HEAD ITEM: 910000100, LOT: 1103908. HOWMEDICA CABLE SLEEVE SET X 3 ITEM: 3704-0-510, LOT: 031265710901; 031575991603; 031836204605. G2: AUSTRALIA THE CUSTOMER HAS INDICATED THAT THE PRODUCT WAS DISCARDED AND WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: G3; H2; H3; H6. VISUAL EXAMINATION OF THE PROVIDED PICTURE IDENTIFIED THE EXPLANTED ZB LINER ALONG WITH AN UNKNOWN BEARING AND A COMPETITOR HEAD AND STEM. THE LINER HAS SOME BIO DEBRIS ON THE INSIDE EDGES. THERE IS ALSO DAMAGE TO THE EDGES AND THE LINER IS FRACTURED AND DEFORMED OFF ON ONE SIDE. NO FURTHER OBSERVATIONS COULD BE MADE BASED ON THE IMAGE ALONE. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: THE PATIENT UNDERWENT AN INITIAL RIGHT THA. NO DETAILS OF THE IMPLANTED DEVICES WERE PROVIDED. THE PATIENT HAD A REVISION DUE TO ACETABULAR LOOSENING, POLY WEAR DEBRIS AND PROXIMAL FEMORAL OSTEOLYSIS WITH TROCHANTERIC NON-UNION. THE INITIAL IMPLANTS WERE ALL EXPLANTED AND REPLACED WITH A BIOMET SHELL AND BIOMET LINER, ALONG WITH COMPETITOR DEPUY HEAD AND J&J STEM. NO INTRAOPERATIVE COMPLICATIONS NOTED. THEN THE PATIENT UNDERWENT A SECOND REVISION DUE TO BROKEN COMPETITOR STEM. THE BIOMET LINER, COMPETITOR STEM AND COMPETITOR HEAD WERE EXPLANTED. A REPLACEMENT RINGLOC LINER WAS IMPLANTED. THE BIOMET SHELL WAS RETAINED. NO OPERATIVE NOTES WERE PROVIDED FOR THE REVISION. A PRE-OP X-RAY WAS PROVIDED; HOWEVER, IT WAS NOT FURTHER REVIEWED AS IT WAS NOT DATED, AND THE IMAGE HAD OVERLAPPING MARKINGS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. HOWEVER, IT WAS IDENTIFIED THAT THE BIOMET LINER AND ASSOCIATED BIOMET SHELL WERE USED WITH COMPETITOR PRODUCTS; J&J DEPUY STEM AND HEAD. ZIMMER BIOMET HAS NOT CONFIRMED THE COMPATIBILITY FOR THESE COMBINATIONS OF DEVICES. IT IS UNKNOWN IF THESE OFF-LABEL USAGES MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENTS. PLEASE NOTE, PER THE IFU 01-50-0961 BIOMET HIP JOINT REPLACEMENT PROSTHESES, IT STATES, ONLY AUTHORIZED COMBINATIONS SHOULD BE USED AND ZIMMER OR BIOMET IS NOT LIABLE FOR COMPLICATIONS THAT MAY ARISE FROM THE USE OF THE DEVICE IN CIRCUMSTANCES OUTSIDE OF ZIMMER OR BIOMET¿S CONTROL INCLUDING, BUT NOT LIMITED TO, PRODUCT SELECTION AND DEVIATIONS FROM THE DEVICE¿S INDICATED USES OR SURGICAL TECHNIQUE. 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 TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 22 YEARS POST-IMPLANTATION DUE TO A BROKEN COMPETITOR STEM. DURING THE PROCEDURE, THE RINGLOC LINER WAS FOUND DAMAGED. THE STEAM, HEAD, AND LINER WERE ALL REVISED. NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

    Description of Event or Problem · 0

    DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2466203 CERAMIC RNGLC ACET LINER 23/28 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 245230

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Hospitalization| R SEE H11