BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS AVL TIB BEARING 12MM

    MDR report key: 21035659 · Received December 30, 2024

    Report

    Report Number
    0001825034-2024-03061
    Event Type
    Injury
    Date Received
    December 30, 2024
    Date of Event
    December 2, 2024
    Report Date
    May 28, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00880304456136
    PMA / PMN Number
    K051570
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ADDITIONAL ASSOCIATED PRODUCTS: 161071 OSS AVL POLY TIB BUSHING SET LOT# 65904789, 150510 OSS POLY BUMPER LOCK PIN LOT# 65713123, 161073 OSS AVL TIBIAL LOCK RING LOT# 839670, 161035 OSS RS AXLE LOT# 66008365, 161075 OSS AVL YOKE 12MM LOT# 663900, 161034 OSS RS POLY FEM BUSHINGS SET/2 LOT# 66257611.

    Additional Manufacturer Narrative · 0

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE WAS REQUESTED BUT NOT RETURNED BY THE FACILITY. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. ADDITIONAL ASSOCIATED PRODUCTS: 161071 OSS AVL POLY TIB BUSHING SET LOT# 65904789. 150510 OSS POLY BUMPER LOCK PIN LOT# 65713123. 161073 OSS AVL TIBIAL LOCK RING LOT# 839670.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B4, B5, G3, G6, H1, H2, H3, H6, H10, H11. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE EXPLANTED TIBIAL BUSHING, POLY LOCK PIN AND AVL LOCKING RING ARE FOUND FRACTURED. AS THE DEVICES WERE NOT RETURNED, FURTHER EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. INSUFFICIENT INFORMATION PROVIDED TO PERFORM A COMPATIBILITY CHECK. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: FOR NOTES: PATIENT STATES SHE WOKE UP AND THE KNEE HYPEREXTENDED AND WAS ACCOMPANIED WITH SIGNIFICANT PAIN AND WAS UNABLE TO BEAR WEIGHT. SEEN IN THE ER THE NEXT DAY, CT SHOWED A METAL FRAGMENT NEXT TO THE LATERAL TIBIA OF THE LEFT KNEE. PATIENT WAS PLACED IN AN IMMOBILIZER. RADIOGRAPHS SHOW FAILURE OF INTERNAL HINGE MECHANISM. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: IMPLANT FIT IS MAINTAINED. THERE IS MILD LATERAL PATELLAR TILT AND SUBLUXATION. BONE QUALITY IS OSTEOPENIC. THERE ARE CONTOUR DEFORMITIES OF THE TIBIAL IMPLANT AS MARKED ON THE IMAGES FOR WHICH COMPARISON WITH EARLIER IMAGES WOULD BE NECESSARY TO DETERMINE EARLY IMPLANT DISASSEMBLY AND FAILURE. COMPLAINT IS CONFIRMED WITH THE PROVIDED PICTURES AND MEDICAL RECORDS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT TOTAL KNEE REVISION. THREE MONTHS POSTOP, THE PATIENT REPORTED FALLING AND RUPTURED THE MEDIAL RETINACULAR AND UNDERWENT AN IRRIGATION AND DEBRIDEMENT TO ENSURE THERE WAS NO INFECTION AND THE CAPSULE WAS NOT DAMAGED. NO IMPLANTS WERE EXCHANGED. SIX MONTHS AFTER THE FALL, THE PATIENT REPORTS SHE WOKE UP AND HYPEREXTENDED HER KNEE RESULTING IN PAIN AND THE INABILITY TO BEAR WEIGHT. X-RAY IMAGES SHOWED METAL FRAGMENTS FROM THE LOCKING RING AND POLY FRAGMENTS IN THE JOINT. THE PATIENT WAS REVISED ONE MONTH LATER IN WHICH THE METAL AND POLY HINGE MECHANISMS WERE REPLACED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BEARING COMPONENTS FAILED(FRACTURED) AFTER NO SIGN OF TRAUMA TO THE KNEE. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED 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
    2128154 OSS AVL TIB BEARING 12MM PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 416590 00880304456136

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H SEE H11 NARRATIVE.