BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Z1 STD COL CMTLESS SZ 6

    MDR report key: 23292732 · Received October 15, 2025

    Report

    Report Number
    0001822565-2025-03738
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 22, 2025
    Report Date
    January 26, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    UDI-DI
    00887868575518
    PMA / PMN Number
    K233476
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: BIOLOX DELTA HD 12/14 36X+3.5. ITEM: 00-8775-036-03. LOT: 3235665. 36MM I.D. SIZE F NEUTRAL LINER. ITEM: 30103606. LOT: 67352087. G7 PPS LTD ACET SHELL 54F. ITEM: 010000664. LOT: J7777524. PR Z1 ST/G7 CP/VE LN/CER HD. ITEM: 98-0005-003-04. LOT: UNKNOWN. H6: PROPOSED COMPONENT CODE: MECHANICAL (G04) ¿ STEM THE CUSTOMER HAS INDICATED THAT THE PRODUCT REMAINS IMPLANTED. 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. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: THE IMAGES SHOW A SMALL GAP BETWEEN THE CALCAR AND COLLAR OF THE FEMORAL STEM WHICH WOULD COINCIDE WITH SURGEON REPORT OF A PERCHED STEM. IT IS NOT POSSIBLE TO DETERMINE IF THE PPS COATING IS THE CAUSE FROM THESE IMAGES-PER THE LITERATURE, PERFECT CALCAR-COLLAR CONTACT IS ACHIEVED IN LESS THAN 50% OF COLLARED STEMS AND THERE ARE SEVERAL POSSIBLE CAUSES FOR IMPROPER COLLAR-CALCAR CONTACT INCLUDING (BUT NOT LIMITED TO) LOW FEMORAL OSTEOTOMY OR ROTATION OF THE COMPONENT IN RELATION TO THE FINAL BROACH. 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 TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FINAL STEM IMPLANTATION PERCHED A COUPLE MILLIMETERS. THE SURGEON NOTED THAT THE PPS COATING IS THICK AND NEEDS TO BE REDUCED TO ALLOW ACCURATE 1:1 BROACH TO STEM. NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2018784 Z1 STD COL CMTLESS SZ 6 PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. ZB2500689 00887868575518

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male