BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS 25MM BSPLT HA+ADPTR

    MDR report key: 17073066 · Received June 6, 2023

    Report

    Report Number
    0001825034-2023-01283
    Event Type
    Injury
    Date Received
    June 6, 2023
    Date of Event
    May 11, 2023
    Report Date
    December 21, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00880304532465
    PMA / PMN Number
    K193373
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, 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: 0001825034-2023-01268, 0001825034-2023-01269, 0001825034-2023-01270, 0001825034-2023-01271, 0001825034-2023-01272, 0001825034-2023-01273, 0001825034-2023-01274. D10: MEDICAL PRODUCTS: ITEM#: 115310, COMP RVRS SHLDR GLNSP STD 36MM; LOT#: 293460, ITEM#: 115370, COMP RVS TRAY CO 44MM; LOT#: 417500, ITEM#: EP-115393, E1 44-36 STD HMRL BRNG; LOT#: 520070, ITEM#: 115396, COMP RVS CNTRL 6.5X30MM ST/RST; LOT#: 583320, ITEM#: 180550, COMP LK SCR 3.5HEX 4.75X15 ST; LOT#: 365550, ITEM#: 180553, COMP LK SCR 3.5HEX 4.75X30 ST; LOT#: 890170, ITEM#: 180557, COMP NLK SCR 3.5HEX 4.75X15 ST; LOT#: 540130. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. 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: 0001825034-2023-01268-1 , 0001825034-2023-01269-1, 0001825034-2023-01270-1, 0001825034-2023-01271-1, 0001825034-2023-01272-1, 0001825034-2023-01273-1, 0001825034-2023-01274-1. 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 AND CORRECTED INFORMATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THE BASEPLATE HAS WEAR ON THE FACE OF THE PART. TAPER ADAPTER SHOWS HEAVY SIGNS OF DAMAGE AND A V-SHAPE WEARING OF THE METAL. OTHER DEVICES EXPLANTED SHOW SIGNS OF USE AND WEAR. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: MAY 11, 2023, OP NOTE: SIGNIFICANT FINDINGS DURING THE SURGERY INCLUDE SEVERE METALLOSIS THROUGHOUT THE SHOULDER JOINT, LOOSENING OF THE BASEPLATE, CRESCENT PATTERN WEAR TO THE POLY, V-SHAPED WEAR TO THE TRUNNION, AND EROSION AND SEVERE OSTEOLYSIS TO THE GLENOID. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: A REVERSE TYPE RIGHT SHOULDER ARTHROPLASTY IS PRESENT. THERE IS ABNORMAL ALIGNMENT OF THE GLENOSPHERE WITH THE BASEPLATE CONSISTENT WITH GLENOSPHERE DISASSOCIATION. THERE IS NO OSSEOUS FRACTURE, EVIDENCE OF IMPLANT LOOSENING, OR ABNORMAL RADIOLUCENCY. BONE QUALITY IS OSTEOPENIC. IMPLANT FIT IS MAINTAINED. 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 A RIGHT SHOULDER REVERSE TOTAL SHOULDER ARTHROPLASTY APPROXIMATELY SEVEN (7) YEARS AND FIVE (5) MONTHS AGO, SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO METALOSIS OF THE IMPLANTS. THE PATIENT IS SCHEDULED FOR A SECOND REVISION SURGERY IN APPROXIMATELY THREE (3) WEEKS TO IMPLANT CUSTOM IMPLANTS AND COMPLETE THE REVISION.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT HAD A RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT BEGAN TO EXPERIENCE PAIN, MECHANICAL INSTABILITY, AND A CLUNKING SENSATION. RADIOGRAPHIC IMAGING DISPLAYED DISASSOCIATION OF THE IMPLANT AND THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY SEVEN AND HALF YEARS AFTER THE INITIAL SURGERY. DURING THE SURGERY IT WAS FOUND THAT THERE WAS SEVERE METALLOSIS THROUGHOUT THE JOINT, LOOSENING OF THE BASEPLATE, AND EROSION AND SEVERE OSTEOLYSIS TO THE GLENOID. DUE TO BONE STOCK OF THE GLENOID THE SURGEON PERFORMED THE FIRST STAGE OF A TWO-STAGE REVISION SURGERY. ALL IMPLANTS WERE REVISED EXCEPT FOR THE HUMERAL STEM AS IT WAS WELL FIXED AND A ANTIBIOTIC SPACER WAS PLACED UNTIL THE STAGE TWO REVISION COULD BE COMPLETED. ALL IMPLANTS WERE REVISED EXCEPT THE HUMERAL STEM AS IT WAS WELL FIXED, AND AN ANTIBIOTIC SPACER WAS IMPLANTED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020601 COMP RVRS 25MM BSPLT HA+ADPTR SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES PHX ZIMMER BIOMET, INC. 010000589 697110 00880304532465

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention| H SEE H10 NARRATIVE