BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRX HUM LO PLT RT 14H 227MM

    MDR report key: 11638278 · Received April 8, 2021

    Report

    Report Number
    0001825034-2021-01017
    Event Type
    Injury
    Date Received
    April 8, 2021
    Date of Event
    March 12, 2021
    Report Date
    July 9, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRS
    PMA / PMN Number
    K143697
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS CONFIRMED AS X-RAYS SHOWED THAT THE HUMERAL PLATE IS FRACTURED ALONG ITS MID ASPECT. NO SIGNS OF LOOSENING, WEAR, RADIOLUCENCY. FRACTURE OF THE MID-PORTION OF A HUMERAL PLATE IS IDENTIFIED. NO CONTRIBUTING FACTORS ARE SEEN. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE COULD NOT 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.

    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.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: CATALOG #: 816135020, 3.5MM CORT LOCK SCR 20MM NS, LOT # UNKNOWN. CATALOG #: 816135020, 3.5MM CORT LOCK SCR 20MM NS, LOT # UNKNOWN. CATALOG #: 816135020, 3.5MM CORT LOCK SCR 20MM NS, LOT # UNKNOWN. CATALOG #: 110030204, PRX HUM LO PLT RT 14H 227MM, LOT # UNKNOWN. CATALOG #: 816135042, 3.5MM CORT LOCK SCR 42MM NS, LOT # UNKNOWN. CATALOG #: 816135042, 3.5MM CORT LOCK SCR 42MM NS, LOT # UNKNOWN. CATALOG #: 816135048, 3.5MM CORT LOCK SCR 48MM NS, LOT # UNKNOWN. CATALOG #: 816135050, 3.5MM CORT LOCK SCR 50MM NS, LOT # UNKNOWN. CATALOG #: 816135052, 3.5MM CORT LOCK SCR 52MM NS, LOT # UNKNOWN. CATALOG #: 816135054, 3.5MM CORT LOCK SCR 54MM NS, LOT # UNKNOWN. CATALOG #: 110017726, SCREW T15 LP CORT 3.5X26MM NS, LOT # UNKNOWN. CATALOG #: 110017728, SCREW T15 LP CORT 3.5X28MM NS, LOT # UNKNOWN.. CATALOG #: 110017728, SCREW T15 LP CORT 3.5X28MM NS, LOT # UNKNOWN. CATALOG #: 110017728, SCREW T15 LP CORT 3.5X28MM NS, LOT # UNKNOWN. CATALOG #: 110017728, SCREW T15 LP CORT 3.5X28MM NS, LOT # UNKNOWN. CATALOG #: 110017732, SCREW T15 LP CORT 3.5X32MM NS, LOT # UNKNOWN. CATALOG #: 110017734, SCREW T15 LP CORT 3.5X34MM NS, LOT # UNKNOWN. CATALOG #: 110017736, SCREW T15 LP CORT 3.5X36MM NS, LOT # UNKNOWN. CATALOG #: 110017736, SCREW T15 LP CORT 3.5X36MM NS, LOT # UNKNOWN. CATALOG #: 110017738, SCREW T15 LP CORT 3.5X38MM NS, LOT # UNKNOWN. CATALOG #: KW20SS, S3 K-WIRE 2.0X152MM (6 IN) NS, LOT # UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENTS ORIGINAL CASE WAS APPROXIMATELY THREE WEEKS BEFORE HARDWARE REMOVAL. USED A LONG 14 HOLE PROXIMAL HUMERUS PLATE. THE PLATE BROKE IN THE DISTAL SHAFT AT A LOCKING HOLE JUST PROXIMAL TO A OVAL COMPRESSION HOLE. THERE WERE NO SIGNS OF A FALL OR IMPACT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531507 PRX HUM LO PLT RT 14H 227MM PROSTHESIS SHOULDER HRS ZIMMER BIOMET, INC. N/A RM994N

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O