BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURAL TIBIA TRAB METAL TWO-PEG POROUS FIXED BEARING LEFT

    MDR report key: 6182906 · Received December 16, 2016

    Report

    Report Number
    0001822565-2016-04709
    Event Type
    Injury
    Date Received
    December 16, 2016
    Date of Event
    December 5, 2017
    Report Date
    August 14, 2018
    Manufacturer
    ZIMMER, INC.
    Product Code
    MBH
    PMA / PMN Number
    PK121771
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN A THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    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

    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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ADVERSE EVENT ONLY. CONCOMITANT PRODUCT: ALL POLY PATELLA CEMENTED 35 MM DIAMETER CATALOG# 42540000035 LOT# 62401095. FEMUR TRABECULAR METAL CRUCIATE RETAINING (CR) NARROW POROUS CATALOG# 42502206201 LOT# 62440480. ARTICULAR SURFACE FIXED BEARING ULTRACONGRUENT (UC) LEFT 14 MM HEIGHT CATALOG# 42512200414 LOT# 62277091. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. OPERATIVE NOTES FROM THE PRIMARY SURGERY STATE THE PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS. DURING TRIALING IT WAS NOTED THAT THE POSTERIOR CRUCIATE LIGAMENT WAS INSUFFICIENT SO A UC ARTICULAR SURFACE WAS USED. THE TIBIAL AND FEMORAL COMPONENTS WERE IMPLANTED WITH PRESS-FIT TECHNIQUE AND THE PATELLAR COMPONENT WAS CEMENTED IN PLACE. GOOD FLEXION AND EXTENSION WITH GOOD PATELLA STABILITY WERE NOTED WITH THE CEMENTED COMPONENTS. POST-OPERATIVE PATIENT FOLLOW-UP VISIT STATES THAT X-RAYS TAKEN SHOW OBVIOUS SUBSIDENCE OF THE TM TIBIAL COMPONENT. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. (B)(4). THIS REPORT IS NUMBER 3 OF 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1822565-2016-03948, 04708, 04709, 04710).

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 · 1

    PATIENT REPORTED EXPERIENCING LIMITED RANGE OF MOTION, LIMPING, PAIN, SWELLING, TIBIAL AND SHIN PAIN AND TIBIAL COMPONENT SUBSIDING. PATIENT WAS PRESCRIBED PHYSICAL THERAPY BUT WAS NON-COMPLIANT. ADDITIONAL INFORMATION RECEIVED INDICATES THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY FOUR YEARS POST-IMPLANTATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    REVIEW OF MEDICAL RECORDS DETERMINED THERE WAS GROSS FLEXION INSTABILITY IN ALL DIRECTIONS, RESIDUAL TIBIAL BONE NOTED ANTERIOR AND LATERALLY WITH CONSIDERABLE MENISCAL MATERIAL REMAINING, LARGE RETAINED POSTERIOR CONDYLAR FEMORAL OSTEOPHYTES, AND NO LOOSENING, MIGRATION OR WEAR NOTED.

    Description of Event or Problem · 1

    PATIENT REPORTED EXPERIENCING LIMITED RANGE OF MOTION, LIMPING, PAIN, SWELLING, TIBIAL AND SHIN PAIN AND TIBIAL COMPONENT SUBSIDING. PATIENT WAS PRESCRIBED PHYSICAL THERAPY BUT WAS NON-COMPLIANT. NO REVISION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833142 NATURAL TIBIA TRAB METAL TWO-PEG POROUS FIXED BEARING LEFT PROSTHESIS, KNEE MBH ZIMMER, INC. N/A 62337339

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| O| R