BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM XL 44-36 STD HMRL BRNG

    MDR report key: 6137123 · Received November 30, 2016

    Report

    Report Number
    0001825034-2016-04919
    Event Type
    Injury
    Date Received
    November 30, 2016
    Date of Event
    July 27, 2016
    Report Date
    March 29, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    PAO
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-04949 / 04919).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). CONCOMITANT MEDICAL PRODUCT: COMP FX HUM POS SLEEVE 16MM, CAT#: 113584 LOT#: 094320; COMP NLK SCR 3.5HEX 4.75X30 ST, CAT#: 180560 LOT#: 140060; COMPR 14MM HUM FRACT STEM PPS, CAT#: 12-113564 LOT#: 115510; COMP FX HUM POS SLEEVE 17MM, CAT#: 113585 LOT#: 804120; COMP RVS CNTRL 6.5X25MM ST/RST, CAT#: 115395 LOT#: 456790; COMP LK SCR 3.5HEX 4.75X35 ST, CAT#: 180554 LOT#: 895030; COMP LK SCR 3.5HEX 4.75X30 ST, CAT#: 180553 LOT#: 425730; COMP LK SCR 3.5HEX 4.75X30 ST, CAT#: 180553 LOT#: 704610; COMP LK SCR 3.5HEX 4.75X25 ST, CAT#: 180552 LOT#: 871390; COMP. REV SHLDR 9 IN STEINMANN, CAT#: 405800 LOT#: 562530; COMP RVS TRAY +5MM CO 44MM, CAT#: 115375 LOT#: 955200; COMP RVRS 25MM BSPLT HA+ADPTR, CAT#: 010000589 LOT#: 342420. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED [LOCATION UNKNOWN] 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: 0001825034-2016-04919 AND 0001825034-2017-01976.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO 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 · 1

    IT WAS REPORTED THAT DURING A REVERSE SHOULDER PROCEDURE, UPON OPENING THE IMPLANT PACKAGE, THE TRUNNION OF THE BASEPLATE WAS NOTICED TO BE COVERED IN SCRATCHES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SHOULDER REVISION DUE TO DISLOCATION APPROXIMATELY 1 YEAR POST-IMPLANTATION. ALL COMPONENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786967 ARCOM XL 44-36 STD HMRL BRNG PROSTHESIS, SHOULDER PAO BIOMET ORTHOPEDICS N/A 127820 

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R