BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING

    MDR report key: 9270704 · Received November 3, 2019

    Report

    Report Number
    0001825034-2019-04952
    Event Type
    Injury
    Date Received
    November 3, 2019
    Report Date
    September 30, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00880304543133
    PMA / PMN Number
    K132239
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MEDICAL PRODUCT: CATALOG #: 180561, COMP NLK SCR 3.5HEX 4.75X35 ST, LOT # 251830 CATALOG #: 180552, COMP LK SCR 3.5HEX 4.75X25 ST, LOT # 593030 CATALOG #: 180553, COMP LK SCR 3.5HEX 4.75X30 ST, LOT # 472190 CATALOG #: 180560, COMP NLK SCR 3.5HEX 4.75X30 ST, LOT # 541780 REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-04986, 0001825034-2019-04987, 0001825034-2019-04988, 0001825034-2019-04991.

    Additional Manufacturer Narrative · 0

    (B)(4). 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). THE REPORTED EVENT IS NOT CONFIRMED; HOWEVER, REVIEW OF THE REVISION OPERATIVE NOTE AND IMPLANT LOGS CONFIRMED INCOMPATIBLE IMPLANTS USED (NON-ZIMMER BIOMET IMPLANTS). MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: PATIENT UNDERWENT LEFT REVERSE TOTAL SHOULDER ABOUT 10 YEARS AGO. SUBSEQUENTLY A MONTH LATER UNDERWENT REVISION DUE TO BONE EROSION (NOTCHING) HO, AND BASEPLATE POSITIONING. RETAINED WELL FIXED STEM REVISED HUMERAL TRAY & BEARING. GLENOSPHERE COMPONENTS REVISED TO COMPETITOR PRODUCTS. MEDICAL RECORDS RELATED TO ONGOING PAIN WERE NOT PROVIDED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AS IT IS UNKNOWN WHAT IS CAUSING THE REPORTED PAIN. HOWEVER, MEDICAL RECORDS PROVIDED STATE THAT THE IMPLANTS WERE USED WITH COMPETITOR IMPLANTS, WHICH ARE NOT COMPATIBLE. THE USE OF INCOMPATIBLE IMPLANTS IS CONSIDERED OFF-LABEL USE. 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

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT LEFT REVERSE TOTAL SHOULDER APPROXIMATELY 8 YEARS AGO. SUBSEQUENTLY ABOUT A YEAR LATER THE PATIENT UNDERWENT REVISION DUE TO BONE EROSION (NOTCHING) HO, AND BASEPLATE POSITIONING. THE PATIENT RETAINED WELL FIXED STEM AND HAD THE HUMERAL TRAY & BEARING REVISED. GLENOSPHERE COMPONENTS REVISED TO COMPETITOR PRODUCTS. SUBSEQUENTLY THE PATIENT REPORTS OF ONGOING PAIN SINCE THE REVISION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). UDI# (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG #: 115310, COMP RVRS SHLDR GLNSP STD, LOT # 670930, CATALOG #: 115330, COMP RVRS SHDR GLEN BSPLT, LOT # 415440, CATALOG #: 113653, COMP PRIMARY STEM 13MM STD, LOT # 921870, CATALOG #: 118001, VERSA-DIAL/COMP TI STD TAPER, LOT # 411920, CATALOG #: EP-115395, E1 44-36 RTNV +3 HMRL BRG, LOT # 386560, CATALOG #: 115378, COMP RVS TRAY +10MM CO 44MM, LOT # 800090. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-04951, 0001825034-2019-04952, 0001825034-2019-04953, 0001825034-2019-04954, 0001825034-2019-04955, 0001825034-2019-04956, 0001825034-2019-04957. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT IS STILL EXPERIENCING PAIN APPROXIMATELY TWO YEARS POST-IMPLANTATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065013 COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING PROSTHESIS SHOULDER KWS ZIMMER BIOMET, INC. N/A 386560 00880304543133

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other SEE H10 NARRATIVE.| SEE H10 NARRATIVE.