BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS TIBIAL POLY BEARING 12MM

    MDR report key: 17513178 · Received August 11, 2023

    Report

    Report Number
    0001825034-2023-01873
    Event Type
    Injury
    Date Received
    August 11, 2023
    Report Date
    September 29, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    K052685
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, G3, G6, H2, H3, H6, AND H10. REPORTED EVENT WAS CONFIRMED BY REVIEW OF PHOTOGRAPH. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED SIGNS OF USE AND THAT THE IMPLANT WAS FRACTURED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D6A IMPLANT DATE: UNKNOWN DATE IN 2011. D10 MEDICAL DEVICES: OSS TIB BLK AUG 10X63/67 UNIV CATALOG#: 150426 LOT#: 915790. OSS TIB BLK AUG 10X63/67 UNIV CATALOG#: 150426 LOT#: 264550. OSS REINFORCED YOKE CATALOG#: 150493 LOT#: 027350. OSS AXLE CATALOG#: 150480 LOT#: 044050. OSS 3CM RESURFACING FEMORAL RT CATALOG#: 150350 LOT#: 940990. OSS NON-MOD TIB PLATE LONG 67 CATALOG#: 150420 LOT#: 797070. OSS POLY FEMORAL BUSHINGS CATALOG#: 150477 LOT#: 229680. OSS POLY TIBIAL BUSHING CATALOG#: 150476 LOT#: 668090. OSS POLY LOCK PIN CATALOG#: 150478 LOT#: 259160. OSS CMNTD PROX TIB STEM 11X150 CATALOG#: 150445 LOT#: 098570. G2 FOREIGN SOURCE: AUSTRALIA. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT WAS REQUESTED BUT WAS NOT RETURNED BY THE HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    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 THE PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY TWELVE YEARS POST-IMPLANTATION DUE TO FRACTURE OF THE TIBIAL BEARING. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2217596 OSS TIBIAL POLY BEARING 12MM PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 969660

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H SEE H10