BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS TIBIAL POLY BEARING

    MDR report key: 20629825 · Received November 7, 2024

    Report

    Report Number
    0001825034-2024-02622
    Event Type
    Injury
    Date Received
    November 7, 2024
    Date of Event
    May 30, 2024
    Report Date
    April 8, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00880304239388
    PMA / PMN Number
    K002757
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS PROVIDED. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. MEDICAL RECORDS REVIEW INDICATES THERE IS REVISION OF RIGHT TKA FOR RECURRENT DISLOCATION OF OSS-TYPE HINGED KNEE PROSTHESIS. REMOVAL OF THE HINGE, EASY REMOVAL WITHOUT BONE DAMAGE OF THE TIBIAL IMPLANT. TIBIAL REPLACEMENTS CEMENTED WITHOUT COMPLICATION. PLACEMENT OF THE LOCKED HINGE ON THE FEMUR AND TIBIA. 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). D10 - MEDICAL PRODUCT: OPTIPAC 60 REFOB BONE CMT R-3, CATALOG # 4711500396-3, LOT # UNK; UNK FEMORAL STEM, CATALOG # UNK, LOT # UNK; OSS 7CM SEG ELLIPT FEMORAL RT, CATALOG # 150356, LOT # 761990; OSS POLY FEMORAL BUSHINGS, CATALOG # 150477, LOT # 66184050; OSS AXLE, CATALOG # 150480, LOT # 66097344; OSS POLY LOCK PIN, CATALOG # 150478, LOT # 65676154; OSS REINFORCED YOKE, CATALOG # 150493, LOT # 66077093; OSS TIB BLK AUG 10X63/67 UNIV, CATALOG # 150426, LOT # 66008034; OSS TIB BLK AUG 10X79/83 UNIV, CATALOG # 150428, LOT # 696020; OSS NON-MOD TIB PLATE LONG 63, CATALOG # 150419, LOT # 66153805; OSS POLY TIBIAL BUSHING, CATALOG # 150476, LOT # 65733841. G2: BELGIUM. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. D10: REFOBACIN CEMENT REF (B)(4). LOT AW29BE0809.

    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 PATIENT UNDERWENT A REVISION PROCEDURE THREE MONTHS POST IMPLANTATION DUE TO RECURRENT DISLOCATION. THE TIBIAL COMPONENTS WERE REVISED WHILE THE FEMORAL COMPONENTS REMAINED INTACT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1625324 OSS TIBIAL POLY BEARING PROSTHESIS KNEE JDI ZIMMER BIOMET, INC. N/A 65790754 00880304239388

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H10 NARRATIVE