BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACETABULAR PRESSURIZER SMALL

    MDR report key: 22076798 · Received May 23, 2025

    Report

    Report Number
    3006946279-2025-00060
    Event Type
    Injury
    Date Received
    May 23, 2025
    Report Date
    October 10, 2025
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D4: THIS DEVICE IS SOLD OUTSIDE THE US, AND THEREFORE, NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). THE PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER IS NOT APPLICABLE AS THE DEVICE'S LOT NUMBER IS UNKNOWN. D10: ITEM NAME: HANDLE ACETABULAR PRESS; ITEM NUMBER: 4318; LOT: UNKNOWN. G2 ¿ FOREIGN ¿ NETHERLANDS. THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K193038. 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 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H3, H6, H10, H11. 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. REVIEW OF THE COMPLAINT HISTORIES FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THESE ITEMS. A DEFINITIVE ROOT CAUSE OF THE HEALTHCARE PROFESSIONAL INJURY COULD NOT BE DETERMINED. HOWEVER, THE INVESTIGATION INDICATES THAT BOTH INSTRUMENTS ARE NOT COMPATIBLE IN TERMS OF DIAMETER. THIS COULD BE A POSSIBLE CONTRIBUTING FACTOR TO THE REPORTED EVENT. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SCRUB NURSE SUSTAINED A BRUISED FINGERNAIL INJURY WHEN HER HAND SLIPPED WHILE ATTACHING A NEW, UNUSED DISPOSABLE TO A SURGICAL INSTRUMENT IN THE PREPARATION AREA BEFORE SURGERY. THEIR FINGER STRUCK THE INSTRUMENT TABLE DURING THE INCIDENT. INITIAL AND FOLLOW-UP X-RAYS SHOWED NO FRACTURES, BUT DUE TO ONGOING PAIN, SURGERY WAS LATER PERFORMED (DETAILS UNKNOWN). THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. NO DEFECTS WERE FOUND IN THE INSTRUMENT OR THE DISPOSABLE, AND ALL PROCEDURES WERE CORRECTLY FOLLOWED. THE INCIDENT DID NOT IMPACT THE SURGERY; NO COMPONENTS BROKE OR DEVIATED FROM NORMAL USE. ATTEMPTS HAVE BEEN MADE AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.

    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
    2514064 ACETABULAR PRESSURIZER SMALL ACETABULAR PRESSURIZER S LXH BIOMET FRANCE S.A.R.L. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| O SEE H10 NARRATIVE