BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVS CNTRL 6.5X30MM ST/RST

    MDR report key: 17072997 · Received June 6, 2023

    Report

    Report Number
    0001825034-2023-01271
    Event Type
    Injury
    Date Received
    June 6, 2023
    Date of Event
    May 11, 2023
    Report Date
    December 20, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00880304677081
    PMA / PMN Number
    K193373
    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. 0001825034-2023-01272. 0001825034-2023-01273. 0001825034-2023-01274. 0001825034-2023-01283. 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#: 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. ITEM#: 010000589, COMP RVRS 25MM BSPLT HA+ADPTR; LOT#: 697110. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND 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, 0001825034-2023-01272-1, 0001825034-2023-01273-1, 0001825034-2023-01274-1, 0001825034-2023-01283-1. 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 CORRECTED INFORMATION. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THE PRODUCT WAS NOT THE DIRECT CAUSE OF THE EVENT. THE INITIAL REPORT SHOULD BE VOIDED.

    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 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
    1093473 COMP RVS CNTRL 6.5X30MM ST/RST SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES PHX ZIMMER BIOMET, INC. 115396 583320 00880304677081

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Hospitalization| R SEE H10 NARRATIVE.