BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIO-MODULAR HEMI HUMERAL HEAD

    MDR report key: 14634128 · Received June 8, 2022

    Report

    Report Number
    0001825034-2022-01375
    Event Type
    Injury
    Date Received
    June 8, 2022
    Report Date
    August 22, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-01376. MEDICAL PRODUCTS: ITEM#: UNKNOWN, UNKNOWN BIO-MODULAR HEMI HUMERAL STEM; LOT#: UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT REMAINS IMPLANTED IN THE PATIENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-01376-1 COMPONENT CODES: MECHANICAL (G04) - HEAD 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. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: SINGLE AP VIEW OF THE RIGHT SHOULDER WITH OBLIQUELY ORIENTED LINEAR LUCENCY ALONG THE PROXIMAL TO MID HUMERAL DIAPHYSIS SUGGESTING NONDISPLACED FRACTURE. POSSIBLE LOOSENING OF THE PROXIMAL HUMERAL COMPONENT. NO DISLOCATION. MILD TO MODERATE AC JOINT DEGENERATIVE CHANGE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 HEMI-ARTHROPLASTY ON AND UNKNOWN DATE FOR AN UNKNOWN REASON. SUBSEQUENTLY, THE PATIENT IS SCHEDULED FOR A REVISION SURGERY ON AND UNKNOWN DATE DUE TO AN UNKNOWN REASON.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A RIGHT SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS SCHEDULED FOR A REVISION IN JULY DUE TO BONE FRACTURE AND LOOSENING OF IMPLANT. THE PATIENT CANCELLED THE REVISION SURGERY FOR AN UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318745 UNKNOWN BIO-MODULAR HEMI HUMERAL HEAD SHOULDER PROSTHESIS/EXTREMITIES PHX ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H