BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK BIOMET STEM

    MDR report key: 23487958 · Received November 6, 2025

    Report

    Report Number
    0001825034-2025-03503
    Event Type
    Injury
    Date Received
    November 6, 2025
    Report Date
    November 14, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: G3; H2; H6; H10. THE FOLLOWING SECTIONS WERE CORRECTED: H6 COMPONENT CODE. D4: ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. 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 INVASIVELY DEPENDING ON THE SEVERITY OF THE WOUND INFECTION AND PATIENT STATUS. 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 REVIEW WILL NOT BE COMPLETED FOR LIMITED INVESTIGATION COMPLAINTS AS THE PRODUCT MEETS THE APPLICABLE ACCEPTANCE CRITERIA. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE UNRELATED TO THE DEVICE. COMPLAINT IS NOT CONFIRMED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). B3: JUN 2024. D10: UNK BIOLOX TAPER ADAPTER; CAT# 650-1056 LOT# 3111543 CER BIOLOXD OPTION HD 32MM, H6: SUGGESTED COMPONENT CODE: MECHANICAL (G04) ¿ STEM. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST-HIP PROCEDURE, A DAIR PROCEDURE WAS PERFORMED DUE TO WOUND DEHISCENCE. THE INCISION OPENED INITIALLY ELEVEN DAYS POST-PROCEDURE. ALL IMPLANTS REMAINED IN PLACE WITHOUT COMPLICATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2649753 UNK BIOMET STEM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. UNK

    Patients

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