BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTIPAC 80 BIOMET BC R

    MDR report key: 24828941 · Received April 9, 2026

    Report

    Report Number
    3006946279-2026-00017
    Event Type
    Death
    Date Received
    April 9, 2026
    Date of Event
    February 5, 2026
    Report Date
    April 9, 2026
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LOD
    UDI-DI
    04547038258066
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D4 - THIS PRODUCT IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). G2 - FOREIGN: JAPAN. G4 - THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K172408. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL HIP ARTHROPLASTY (BHA) FOR A FEMORAL NECK FRACTURE USING ENOVIS IMPLANTS. DURING THE PROCEDURE, A SIZE L BONE PLUG WAS INSERTED BUT STOPPED PARTWAY INTO THE MEDULLARY CANAL. AN ATTEMPT WAS THEN MADE TO SWITCH TO A SIZE M BONE PLUG; HOWEVER, AS THE SIZE L BONE PLUG HAD ALREADY BEEN INSERTED FAIRLY DEEPLY, IT WAS DIFFICULT TO REATTACH THE INSERTER. THE ASSISTANT PHYSICIAN SUBSEQUENTLY ADVANCED THE SIZE L BONE PLUG FURTHER INTO THE MEDULLARY CANAL USING A MEASURING IMPACTOR, ALLOWING IT TO REACH THE PLANNED DEPTH. CEMENT WAS THEN APPLIED, AND THE STEM, BIPOLAR CUP, AND FEMORAL HEAD WERE SUCCESSFULLY IMPLANTED. HOWEVER, JUST PRIOR TO WOUND CLOSURE, THE PATIENT EXPERIENCED CARDIAC ARREST. RESUSCITATION EFFORTS RESTORED A HEARTBEAT, AND A POST-OPERATIVE X-RAY REVEALED THAT THE BONE PLUG HAD MIGRATED 4¿5 CM BEYOND THE DISTAL END OF THE STEM. THE PATIENT WAS TRANSFERRED TO THE ICU BUT PASSED AWAY THE SAME DAY. THE PHYSICIAN SUGGESTED THAT A POSSIBLE EMBOLISM MAY HAVE OCCURRED AS A RESULT OF HOW DEEPLY THE BONE PLUG HAD SUNK IN THE MEDULLARY CANAL. THE EXACT CAUSE OF DEATH COULD NOT BE CONFIRMED AS BEING RELATED TO THE IMPLANTS OR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889461 OPTIPAC 80 BIOMET BC R BONE CEMENT LOD BIOMET FRANCE S.A.R.L. AU15DB0319 04547038258066

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Male Death