BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HUMERAL HEAD

    MDR report key: 23004449 · Received September 9, 2025

    Report

    Report Number
    0001825034-2025-02839
    Event Type
    Injury
    Date Received
    September 9, 2025
    Date of Event
    August 12, 2024
    Report Date
    December 17, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: MEDICAL PRODUCTS: ITEM#: UNKNOWN; UNKNOWN HUMERAL STEM; LOT#: UNKNOWN. ITEM#: UNKNOWN, UNKNOWN GLENOID; LOT#: UNKNOWN. G2: FOREIGN: AUSTRALIA. G2: LITERATURE: FULLER J, NIXON R. DELAYED PRESENTATION OF COBALT ALLERGY TO A SHOULDER PROSTHESIS PRESENTING 4 YEARS POST-IMPLANTATION. CONTACT DERMATITIS. 2025; 92(2): 152-153. DOI:10.1111/COD.14710. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. H6: COMPONENT CODES: MECHANICAL (G04) - HEAD. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H6, H11. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. A CASE STUDY WAS PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: THE PT EXPERIENCED INCREASING PAIN OVER TIME, LIMITED ROM, AND BLOTCHY ERYTHEMA OVER THE JOINT THAT INCREASED. 4 YEARS POST OP, THE PT HAD 2 WASHOUTS/I&D DUE TO CONCERNS OF INFECTION. NO SIGNS OF DEEP JOINT INFECTION, BUT GRANULATION TISSUE AND BLACK DISCOLORATION WERE FOUND. TREATED WITH ANTIBIOTICS, AND ID DOCTOR, WITH NO LABS OR SYSTEMIC SIGNS OF INFECTION. LATER IN THE YEAR, THERE WAS NO IMPROVEMENT, SO ELECTED REMOVAL OF IMPLANTS AND A SPACER PLACED. ALLERGY PATCH TESTING DONE ; COBALT POSITIVE; TITANIUM POSITIVE. SERUM COBALT HIGH 33(<20) BUT HAD NO SYMPTOMS OF COBALT TOXICITY. 5 YEARS POST OP, COBALT SERUM REDUCTION TO 22. ADDITIONALLY, THE PT HAD DIAGNOSIS OF METAL REACTION/HYPERSENSITIVITY VS. INFECTION AND UNDERWENT STAGE 2 OF REVISION. IT WAS REPORTED THAT THE PT HAD A DELAYED ALLERGIC REACTION TO THE IMPLANTS. WITHOUT PRODUCT IDENTIFICATION, WE CANNOT REVIEW MANUFACTURING RECORDS TO CONFIRM MATERIAL COMPOSITION OR REVIEW THE IFU TO DETERMINE IF ALLERGY TESTING IS REQUIRED PRIOR TO USE, AND THE CASE STUDY INDICATES THE PATIENT HAD NO PRIOR HISTORY OF A METAL ALLERGY. THEREFORE, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT IS 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT SHOULDER ARTHROPLASTY APPROXIMATELY SIX (6) YEARS AGO. SUBSEQUENTLY, THE PATIENT DEVELOPED ERYTHEMA, PAIN, LIMITED RANGE OF MOTION, AND WAS TREATED FOR POSSIBLE INFECTION WITH ANTIBIOTIC SPACERAPPROXIMATELY ONE (1) YEAR AND NINE (9) MONTHS AGO. IT WAS FINALLY DETERMINED THAT IT WAS METAL RELATED PATHOLOGY/REACTION WITH ELEVATED COBALT LEVEL. THE FINAL IMPLANTS WERE IMPLANTED APPROXIMATELY ONE (1) YEAR AND FIVE (5) MONTHS AGO.

    Description of Event or Problem · 0

    ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2465973 UNKNOWN HUMERAL HEAD SHOULDER PROSTHESIS/EXTREMITIES PHX ZIMMER BIOMET, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention| H