BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEGMENTAL ART SURF, SZ B, 12MM

    MDR report key: 17299582 · Received July 11, 2023

    Report

    Report Number
    0001822565-2023-01877
    Event Type
    Injury
    Date Received
    July 11, 2023
    Date of Event
    April 6, 2017
    Report Date
    January 19, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    K070978
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001822565-2023-01878 , 0002648920-2023-00153, 0001822565-2023-01881. D10-MEDICAL PRODUCT: SEG KNEE POLY INSERT, SZ C, ITEM# 00585001395, LOT# 62162313; LONG 15MM DIAMETER 155MM LENGTH STRAIGHT STEM EXTENSION, ITEM# 00598801115, LOT# 62172241; FLUTED STEM EXTENSION STRAIGHT PRECOAT, ITEM# 00585205017, LOT# 61867926. G2- SPAIN. H3- CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: NO COMPLICATION DURING INITIAL SURGERY. FOLLOW UP NOTE INDICATES THAT THE PATIENT EXPERIENCED HYPEREXTENSION WITHOUT ANY CLICKS AND PAIN. ADDITIONAL NOTE STATES PATIENT UNABLE TO EXTEND DUE TO POSSIBLE RUPTURE OF THE PATELLAR TENDON DUE TO OVERLOAD. A LATER NOTE SAYS MRI CANNOT CONFIRM THE STATUS OF THE PATELLAR TENDON BUT CLINICALLY RUPTURED. THREE YEARS POST OP, PAIN AT THE RUPTURED QUAD TENDON, HE STILL DOES NOT WEAR THE ORTHOSIS WITH EXTENSION LOCK. THE RISK OF ATTEMPTING A RECONSTRUCTION OF THE QUADRICEPS TENDON SEEMS UNAFFORDABLE. PATIENT HAD A FALL AND FRACTURED A BONE NEAR THE TIBIAL STEM, AND IT WAS HEALED. ONE WEEK LATER PATIENT WAS REVISED AS QUADRICEPS TENDON RUPTURE REPAIR WITH MESH AND POLY WAS UPSIZED TO 14MM TO CORRECT RECURVATUM. BASED ON THE INFORMATION FROM A CAPA, IT WAS IDENTIFIED THAT THE POLY BOX IS SUSCEPTIBLE TO DEFORMATION UNDER CERTAIN LOADING CONDITIONS WHICH WAS NOT RECOGNIZED AS A DESIGN INPUT, AND IT LED TO HYPER-EXTENSION OF THE KNEE. THE POLY BOX HAS BEEN REDESIGNED. THEREFORE, REPORTED HYPEREXTENSION IS DUE TO DESIGN ISSUE. HOWEVER. IT UNKNOWN WHETHER THE BONE FRACTURE, TENDON RUPTURE IS DUE TO REPORTED HYPEREXTENSIONS. COMPLAINT IS CONFIRMED BASED ON THE MEDICAL RECORD REVIEW. IF ANY FURTHER INFORMATION IS RECEIVED 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

    IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY THREE YEARS AND EIGHT MONTHS POST IMPLANTATION TO CHRONIC RUPTURE OF THE QUAD TENDON. THE PATIENT UNDERWENT TENDON REPAIR WITH MESH DURING WHICH, THE POLY BEARING WAS UPSIZED TO CORRECT RECURVATUM. APPROXIMATELY SIX WEEKS AFTER INITIAL SURGERY, THE PATIENT REPORTED HYPEREXTENSION OF THE KNEE WITH PARTIAL WEIGHT BEARING. THE PATIENT WAS PROGRESSING WELL BUT WAS INSTRUCTED TO WEAR AN EXTENSION BRACE TO PREVENT FURTHER LOADING ON THE IMPLANT OR SURROUNDING TENDONS. THE PATIENT CONTINUED WEIGHT BEARING ON THE LEG WITHOUT BRACING AND EXPERIENCED RUPTURE OF THE PATELLAR TENDON. THE PATIENT WAS SPLINTED, AND THE SURGEON DECIDED NOT TO REVISE AT THAT TIME PENDING A CUSTOM IMPLANT. APPROXIMATELY THREE YEARS POSTOP, THE PATIENT FELL AND FRACTURED THE TIBIA AT THE TIP OF THE STEM. THE FRACTURE HEALED WITH CONSERVATIVE TREATMENT. THERE IS NO ADDITIONAL INFORMATION 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
    1975516 SEGMENTAL ART SURF, SZ B, 12MM PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 62043776

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Male Hospitalization| R SEE H10