BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM XL 44-36 STD HMRL BRNG

    MDR report key: 9153483 · Received October 3, 2019

    Report

    Report Number
    0001825034-2019-04491
    Event Type
    Injury
    Date Received
    October 3, 2019
    Report Date
    April 4, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). (UDI) - (B)(4). CONCOMITANT MEDICAL PRODUCTS : CATALOG #: 180560, COMP NLK SCR 3.5HEX 4.75X30 ST, LOT # 541780, CATALOG #: 115330, COMP RVRS SHDR GLEN BSPLT +HA, LOT # 415440, CATALOG #: 113653, COMP PRIMARY STEM 13MM STD, LOT # 921870, CATALOG #: 115370, COMP RVS TRAY CO 44MM, LOT # 577900, CATALOG #: XL-115363, ARCOM XL 44-36 STD HMRL BRNG, LOT # 355910, CATALOG #: 118001, VERSA-DIAL/COMP TI STD TAPER, LOT # 411920. 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). UPON ASSESSMENT OF MEDICAL RECORDS IT WAS FOUND THAT THE ISSUE WAS NOT INSTABILITY BUT OF MALPOSTION OF THE BASEPLATE AND NOTCHING. THE TRAY AND HUMERAL BEARING WILL BE VOIDED FOR THE GLENOSPHERE, BASEPLATE, AND TAPER TO BE REPORTED.

    Additional Manufacturer Narrative · 0

    (B)(4). RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: LIMITED EVALUATION OF THE GLENOID AND HUMERAL HARDWARE ARTICULATION SECONDARY TO SUPERIMPOSITION. THIS WOULD REQUIRE ADDITIONAL VIEWS TO FULLY EVALUATE. HOWEVER, SUPERIOR TO THE GLENOHUMERAL ARTICULATION WHICH COULD REPRESENT CHRONICALLY FRACTURED BONE FRAGMENTS OR HETEROTOPIC BONE FORMATION. POTENTIALLY, THIS COULD ACCOUNT FOR LIMITED RANGE OF MOTION AND PATIENT'S DISCOMFORT. OTHERWISE NO OBVIOUS FINDING TO ACCOUNT FOR THE COMPLAINT. MEDICAL RECORDS 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. 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

    UPON ASSESSMENT OF MEDICAL RECORDS IT WAS FOUND THAT THE ISSUE WAS NOT INSTABILITY BUT OF MALPOSTION OF THE BASEPLATE AND NOTCHING. THE TRAY AND HUMERAL BEARING WILL BE VOIDED FOR THE GLENOSPHERE, BASEPLATE, AND TAPER TO BE REPORTED.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THAT THE REASON FOR THE REVISION WAS INSTABILITY.

    Additional Manufacturer Narrative · 1

    (B)(4). (UDI): N/A. MEDICAL PRODUCT: CATALOG #: 115310, COMP RVRS SHLDR GLNSP STD 36MM, LOT # 670930, CATALOG #: 180553, COMP LK SCR 3.5HEX 4.75X30 ST, LOT # 541780, CATALOG #: 180553, COMP LK SCR 3.5HEX 4.75X30 ST, LOT # 472190, CATALOG #: 180552, COMP LK SCR 3.5HEX 4.75X25 ST, LOT # 593030, CATALOG #: 115397, COMP RVS CNTRL 6.5X35MM ST/RST, LOT # 172790, CATALOG #: 180561, COMP NLK SCR 3.5HEX 4.75X35 ST, LOT # 251830, CATALOG #: UNKNOWN, UNKNOWN BASEPLATE, LOT # UNKNOWN, CATALOG #: UNKNOWN, UNKNOWN STEM, LOT # UNKNOWN, CATALOG #: UNKNOWN, UNKNOWN HUMERAL TRAY, LOT # UNKNOWN, CATALOG #: UNKNOWN, UNKNOWN HUMERAL BEARING, LOT # UNKNOWN, CATALOG #: UNKNOWN, UNKNOWN TAPER ADAPTOR, LOT # UNKNOWN. THE CUSTOMER HAS NOT INDICATED WHETHER THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION OR NOT. ONCE THIS INFORMATION IS OBTAINED 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: 0001825034-2019-04389, 0001825034-2019-04480, 0001825034-2019-04482, 0001825034-2019-04483, 0001825034-2019-04484, 0001825034-2019-04485, 0001825034-2019-04487, 0001825034-2019-04488, 0001825034-2019-04490, 0001825034-2019-04492.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT TOTAL REVERSE SHOULDER ARTHROPLASTY SUBSEQUENTLY, THAT PATIENT EXPERIENCED PAIN, LOSS OF RANGE OF MOTION AND LOOSENING OF THE COMPONENTS AND UNDERWENT A REVISION PROCEDURE ONE(1) YEAR ONE(1) MONTH FOURTEEN DAYS (14) MONTHS POST IMPLANTATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948003 ARCOM XL 44-36 STD HMRL BRNG PROSTHESIS SHOULDER KWS ZIMMER BIOMET, INC. N/A 355910

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R SEE H10 NARRATIVE