BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACROM XL 44-41 STD HMRL BRNG

    MDR report key: 7519764 · Received May 16, 2018

    Report

    Report Number
    0001825034-2018-03400
    Event Type
    Injury
    Date Received
    May 16, 2018
    Date of Event
    April 18, 2018
    Report Date
    December 17, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED DISLOCATION WAS CONFIRMED BY REVIEW OF PHOTO, BUT INFECTION COULD NOT BE CONFIRMED. REVIEW OF DEVICE HISTORY RECORDS FOUND THESE UNITS WERE RELEASED TO DISTRIBUTION WITH NO RELATED DEVIATIONS OR ANOMALIES. ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER, IT IS NOTED THAT THE PATIENT IS A RANCHER WHO NEVER STOPPED WORKING WHICH MAY HAVE CONTRIBUTED TO HIS ISSUES. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PART # CP561425, CUST 15CM CPS/MOS INTERC, LOT # 991960 PART # 211218, COMPR SRS PROX BDY - LG , LOT # 539740 PART # 115370, COMP RVS TRAY CO 44MM, LOT 935350 PART # 115320, COMP RVRS SHLDR GLNSP STD 41MM, LOT # 600250 PART # CP111044, CPS CUST SHORT 10MM ANCHOR PLG, LOT # 763280 PART # 178525, CPS TRANSVERSE PIN 6PK 24MM, LOT # 094450 PART # 178526, CPS TRANSVERSE PIN 6PK 28MM, LOT # 823250 PART # CP112306, CUSTOM SHORT CPS SPINDLE, LOT # 377880 PART # 178512, CPS NUT CO-CR-MO ALLOY, LOT # 606520 PART # CP111171, CPS TIB SPINDLE 600LB WASH SET, LOT # 384810 PART # CP110351, COMPRESS 4 BOLT CONCENTRC CLMP, LOT # 365670. 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 A PATIENT UNDERWENT A REVERSE SHOULDER REVISION SURGERY. PHOTOGRAPHS WERE RECEIVED SHOWING PATIENT DISLOCATED AND THERE WAS PERFORATION OF THE SKIN BY THE IMPLANT. PATIENT'S SHOULDER WAS INFECTED, AND DEVICES WERE REVISED. CURRENTLY, THE PATIENT HAS AN ANTIBIOTIC SPACER IN PLACE AWAITING A CUSTOM REPLACEMENT PIECE FOR REVISION. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVERSE SHOULDER REVISION SURGERY. SUBSEQUENTLY, THE PATIENT EXPERIENCED DISLOCATION AND PERFORATION OF THE SKIN BY THE IMPLANT APPROXIMATELY TWO (2) YEARS POST-IMPLANTATION. PATIENT'S SHOULDER WAS INFECTED, AND DEVICES WERE REVISED. CURRENTLY, THE PATIENT HAS A TEMPORARY SPACER IN PLACE, AWAITING A CUSTOM REPLACEMENT PIECE FOR REVISION. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 115320, COMP RVRS SHLDR GLNSP STD 41MM, 600250. PM555567, SORENSEN LT PM MINI GLEN, 082640. THE 115396, COMP RVS CNTRL 6.5X30MM ST/RST, 114200. THE 115397, COMP RVS CNTRL 6.5X35MM ST/RST, 366060. THE 180561, COMP NLK SCR 3.5HEX 4.75X35 ST, 203360. THE 180560, COMP NLK SCR 3.5HEX 4.75X30 ST, 309190. THE 115370, COMP RVS TRAY CO 44MM, 935350. THE 180559, COMP NLK SCR 3.5HEX 4.75X25 ST, 919750. THE 118001, VERSA-DIAL/COMP TI STD TAPER, 323570. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-03401.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY. SUBSEQUENTLY, FOR UNKNOWN REASONS, THE PATIENT HAS EXPERIENCED A DISLOCATION AS WELL AS PENETRATION OF THE SKIN BY THE IMPLANT. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363406 ACROM XL 44-41 STD HMRL BRNG PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 855090

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| O