BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS TIBIAL POLY BEARING 12MM

    MDR report key: 10379442 · Received August 7, 2020

    Report

    Report Number
    0001825034-2020-03066
    Event Type
    Injury
    Date Received
    August 7, 2020
    Date of Event
    July 31, 2020
    Report Date
    January 11, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    K002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CMP-(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D10, D11, G4, G7, H1, H2, H3, H6, H10 D11: ITEM 150493 LOT 254670, ITEM 150476 LOT 510930, ITEM 150480 LOT 745700, ITEM 11-150822 LOT 961580, ITEM 161043 LOT 826550, ITEM 150477 LOT 170160, ITEM 150478 LOT 979820, ITEM 150466 LOT 012560, ITEM 150446 LOT 517770. VISUAL EXAMINATION OF THE RETURNED BEARING FOUND SIGNS OF BEING IMPLANTED WEAR/DISCOLORATION AND IS FRACTURED. DEVICE WAS SUBMITTED FOR FURTHER ANALYSIS. ANALYSIS DETERMINED THE ARTICULAR SURFACE FRACTURE WAS POTENTIALLY CAUSED BY GRADUAL PENETRATION OF THE YOKE INTO THE MATERIAL DUE TO PULLING FORCES IN EXTENSION, FOLLOWED BY SUBSEQUENT FRACTURE DUE TO POTENTIAL OVERLOADING AND THE REDUCED BEARING MATERIAL AND POSSIBLY EXACERBATED BY M/L MISALIGNMENT RESULTING IN KEYWAY IMPINGEMENT, OVERLOADING, AND ABRASION WEAR ON ONE SIDE. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. X-RAYS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW FOUND SHARPLY MARGINATED HYPODENSE OBJECT WITHIN THE POSTERIOR KNEE JOINT AND A JOINT EFFUSION. THIS MOST LIKELY REPRESENTS A DISPLACED POLYETHYLENE IMPLANT. BONE QUALITY APPEARS OSTEOPENIC. PATIENT ANATOMY APPEARS UNREMARKABLE. A DEFINITIVE ROOT CAUSE CANNOT 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 · 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). REPORT SOURCE: FOREIGN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A TOTAL KNEE ARTHROPLASTY AND 42 MONTHS AFTER THE PROCEDURE THE PATIENT FELT A SHARP PAIN AND SWELLING AND WAS REVISED DUE TO A TIBIAL BEARING FRACTURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843833 OSS TIBIAL POLY BEARING 12MM PROSTHESIS, KNEE LZO ZIMMER BIOMET, INC. N/A 755910

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R UNKNOWN FEMORAL COMPONENT| UNKNOWN TIBIAL COMPONENT| UNKNOWN FEMORAL COMPONENT| UNKNOWN TIBIAL COMPONENT