BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIOLOX TAPER +3 NECK

    MDR report key: 23476884 · Received November 5, 2025

    Report

    Report Number
    3002806535-2025-00529
    Event Type
    Injury
    Date Received
    November 5, 2025
    Report Date
    April 3, 2026
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 650-1056 BIOLOX DELTA HEAD G7 32MM LOT# 3111543. UNKNOWN BIOMET SHELL LOT# UNKNOWN. UNKNOWN LINER LOT# UNKNOWN. UNKNOWN BIOMET STEM LOT# UNKNOWN. 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 CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, H2, H6, AND H10. THE FOLLOWING SECTION WAS CORRECTED: H6 COMPONENT CODE. D4: ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. REVIEW OF THE REPORTED EVENT BY A HEALTH CARE PROFESSIONAL FOUND: IT IS EXPECTED THAT A WOUND HEALS IN STAGES AND SHOULD BE OF NORMAL APPEARANCE RELATED TO THE TIMEFRAME SINCE THE INCISION WAS MADE. A SURGICAL WOUND SHOULD BE WELL APPROXIMATED WITHOUT REDNESS, WARMTH, SWELLING AND/OR PURULENT DRAINAGE FOR THE DURATION OF ITS HEALING. THE EXPRESSION ¿WOUND CONCERNS¿ OR "NON-HEALING WOUND¿ WOULD IMPLY THAT THE APPEARANCE OF THE WOUND DEVIATES FROM WHAT A SURGICAL WOUND SHOULD APPEAR. IT MAY BE RED, HAVE DRAINAGE, ADDITIONAL PAIN, WARMTH AND SWELLING AS WELL AS HEALING TIME MAY BE DELAYED. THIS DEVIATION SIGNIFIES AN ALTERATION IN THE WOUND HEALING PROCESS WHICH CAN BE COMPLICATED BY PATIENT COMORBIDITIES SUCH AS DIABETES, OBESITY, SMOKING, AND OTHER CONDITIONS THAT ARE KNOWN TO SLOW A PERSON¿S ABILITY TO HEAL. WOUND COMPLICATIONS CAN BE TREATED CONSERVATIVELY OR MORE INVASIVELY WITH AN IRRIGATION AND DEBRIDEMENT (I&D) WHICH PROMOTES HEALING AT THE SITE AND PREVENTS FURTHER COMPLICATIONS. IF DEEPER EXPLORATION OF THE WOUND IS WARRANTED AND THE JOINT SPACE IS ENTERED, A POLY EXCHANGE IS TYPICALLY PERFORMED IN CONJUNCTION WITH THE I&D TO CLEAR OUT ANY DEBRIS, HEMATOMA FORMATION, OR TO PREVENT DEEP JOINT INFECTION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY WILL NOT BE COMPLETED FOR LIMITED-INVESTIGATION COMPLAINTS, AS THE PRODUCT MEETS THE APPLICABLE REQUIREMENTS. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE UNRELATED TO THE DEVICE. 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 THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. APPROXIMATELY FIVE MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT A REVISION DUE TO THREE RECURRENT DISLOCATIONS. APPROXIMATELY NINE YEARS AFTER THE INITIAL PROCEDURE, A SECOND REVISION WAS PERFORMED DUE TO PAIN AND OSSIFICATION. APPROXIMATELY ELEVEN DAYS AFTER SUTURE REMOVAL, THE SURGICAL WOUND OPENED A COUPLE OF INCHES AFTER THE PATIENT GOT UP TO GO TO THE BATHROOM. SUBSEQUENTLY, A DEBRIDEMENT, ANTIBIOTICS, AND IMPLANT RETENTION (DAIR) PROCEDURE WAS PERFORMED, AND ALL IMPLANTS WERE RETAINED WITHOUT INTRA-OPERATIVE COMPLICATION. THE PATIENT UNDERWENT DAIR, AND THE IMPLANTS REMAINED IN PLACE WITH NO KNOWN COMPLICATIONS REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319878 UNKNOWN BIOLOX TAPER +3 NECK HIP PROSTHESIS LZO BIOMET UK LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H