BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    UNKNOWN HEAD

    MDR report key: 22506857 · Received July 15, 2025

    Report

    Report Number
    0009613350-2025-00580
    Event Type
    Injury
    Date Received
    July 15, 2025
    Date of Event
    June 1, 2025
    Report Date
    April 9, 2026
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D6A. IMPLANT DATE: BETWEEN (B)(6) 2000 AND (B)(6) 2008. D10. UNKNOWN CUP ITEM# UNKNOWN LOT# UNKNOWN. UNKNOW LINER ITEM# UNKNOWN LOT# UNKNOWN. UNKNOWN STEM ITEM# UNKNOWN LOT# UNKNOWN. G2. REPORT SOURCE: UNITED KINGDOM. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS COULD NOT BE PERFORMED DUE TO MISSING LOT NUMBER. A REVIEW OF THE COMPLAINT HISTORY COULD NOT BE PERFORMED DUE TO MISSING REFERENCE AND LOT NUMBERS. BASED ON THE JOURNAL ARTICLE, THE REPORTED EVENT CAN BE CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT 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. LITERATURE: WILLIAMSON TR, KENNEDY IW, JENKINSON MRJ, WHEELWRIGHT B, KANE N, MEEK RMD. DUROM HIP RESURFACING AT 15 YEARS : PREDICTIVE FACTORS FOR FAILURE. BONE JOINT J. 2025 JUN 1;107-B(6 SUPPLE B):55-61. DOI: 10.1302/0301-620X.107B6.BJJ-2024-1045.R1. PMID: 40449549.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4, B5, D2, G1, G3, G6, H1, H2, H11. H1: THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE LITERATURE MDR REPORTING REVIEW AND REMEDIATION EFFORT BASED ON MDR REPORTING PROCESS AND FDA ADVERSE EVENT REPORTING REQUIREMENT. CAPA -07984 WAS OPENED ON FEB 27, 2026 TO ADDRESS CORRECTIONS. DEVICE PERFORMANCE AND/OR RISK PROFILE ARE NOT IMPACTED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    ON 17 JUNE 2025 A JOURNAL ARTICLE WAS RETRIEVED FROM THE BONE & JOINT JOURNAL (2025) THAT REPORTED A STUDY FROM THE UNITED KINGDOM. THE PURPOSE OF THE STUDY WAS TO STUDY THE SURVIVORSHIP OF METAL ON METAL DUROM HIP AT MINIMUM OF 15 YEARS. THE RETROSPECTIVE SINGLE CENTER STUDY REVIEWED DATA BASE DATA FOR 695 HIPS (587 PATIENTS) IMPLANTED CONSECUTIVELY FROM JANUARY 2000 TO DECEMBER 2008. THIS INCLUDED 270 FEMALE HIPS AND 425 MALE HIPS. 7 PATIENTS (7 THA) WERE LOST TO FOLLOW UP AND 7 PATIENTS (9 THA) EXPIRED AND WERE NOT RELATED TO THE SURGERY. DUROM HIP RESURFACING COMPONENT WAS USED IN ALL THE PRIMARY CASES. STANDARD SURGICAL TECHNIQUE AND POSTERIOR APPROACH WAS USED. PRESS-FIT CUP INSERTED WITH 20 DEGREE ANTERVERSION AND INCLINATION ANGLE BETWEEN 35-45 DEGREES. THE STUDY POPULATION HAD A MEAN AGE OF 51.5 YEARS AT TIME OF SURGERY. FOLLOW-UP WAS CONDUCTED AT THREE MONTHS, ONE YEAR AND ANNUALLY THEREAFTER WITH A MEAN FOLLOW-UP OF 18.2 YEARS. THE STUDY REPORTED 8 HIPS UNDERWENT REVISION DUE TO PAIN WITH A MEAN TIME OF REVISION OF 6.9 YEARS. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473437 UNKNOWN HEAD PROSTHESIS, HIP LZO ZIMMER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1