BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE G

    MDR report key: 6347458 · Received February 21, 2017

    Report

    Report Number
    0001822565-2017-01064
    Event Type
    Injury
    Date Received
    February 21, 2017
    Date of Event
    January 24, 2017
    Report Date
    November 8, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    MBH
    PMA / PMN Number
    PK121771
    Removal / Correction Number
    Z-1266-2015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL DEVICES - PERSONA FEMUR TRABECULAR METAL CRUCIATE RETAINING, CATALOG# 42-5028-066-01 LOT# 62573825; NEXGEN TRABECULAR METAL STANDARD PRIMARY PATELLA, CATALOG# 00-5878-065-38, LOT# 62304929; PERSONA VIVACIT-E ARTICULAR SURFACE, CATALOG# 42-5120-006-10, LOT# 62552232. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED THROUGH RECEIPT OF X-RAYS AND REVISION OPERATIVE NOTES. DEVICE WAS NOT RETURNED FOR EVALUATION. X-RAY REVIEW BY A RADIOLOGIST NOTED, "EXCESSIVE POSTERIOR SLOPE OF THE TIBIAL COMPONENT. POSSIBLE SUBSIDENCE POSTERIOR TIBIAL TRAY VERSUS BONE GROWTH AT THE POSTERIOR MARGIN OF THE TIBIAL TRAY. NO BASELINE STUDIES ARE SUBMITTED FOR COMPARISON. PERIARTICULAR OSTEOPENIA IS SUGGESTED WHICH INCREASES RISK OF TIBIAL COMPONENT SUBSIDENCE. TIBIAL COMPONENT IS ALSO NOTED TO BE NONCEMENTED WHICH MAY INCREASE RISK OF TIBIAL COMPONENT SUBSIDENCE IN THE SETTING OF SUBOPTIMAL BONE QUALITY." DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. THE SLOPE MEASUREMENT FROM THE PROVIDED X-RAYS IS APPROXIMATE SO IT CANNOT BE CONSIDERED TO BE DEPARTING FROM THE 7 DEGREE ANGLE RECOMMENDED IN THE SURGICAL TECHNIQUE. ALTHOUGH OSTEOPENIA COULD LEAD TO SUBSIDENCE, OSTEOPENIA IS ONLY SUGGESTED AND IT IS UNKNOWN IF IT WAS PRESENT BEFORE THE PRIMARY TKA PROCEDURE. THEREFORE, IT CANNOT BE DETERMINED IF BONE QUALITY WAS ADEQUATE FOR PRIMARY IMPLANTATION OF THE TM TIBIAL COMPONENT. POSTERIOR SUBSIDENCE COULD HAVE RESULTED DUE TO THE OSTEOPENIC BONE OR FROM ANTERIOR LOOSENING OF THE IMPLANT. THE DEVICE IS ALSO IN SCOPE OF PREVIOUS CORRECTIVE ACTION. IT IS POSSIBLE THAT ALL THESE FACTORS COMBINED TO THE REPORTED EVENT BUT IT IS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE. 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 · 1

    CONCOMITANT MEDICAL PRODUCTS: UNKNOWN PERSONA FEMORAL, ITEM NUMBER: UNKNOWN, LOT NUMBER: UNKNOWN. UNKNOWN ZIMMER PATELLA, ITEM NUMBER: UNKNOWN, LOT NUMBER: UNKNOWN. UNKNOWN PERSONA ARTICULAR SURFACE, ITEM NUMBER: UNKNOWN, LOT NUMBER: UNKNOWN. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT FOLLOWING A TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO PAIN AND TIBIAL LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129363 PERSONA NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE G PROSTHESIS, KNEE MBH ZIMMER, INC. N/A 62475969

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R