BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPS TIB SPINDLE LT 12X37X42MM

    MDR report key: 9069583 · Received September 16, 2019

    Report

    Report Number
    0001825034-2019-04125
    Event Type
    Injury
    Date Received
    September 16, 2019
    Date of Event
    September 26, 2019
    Report Date
    January 28, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K101475
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. WEAR OF THE TIBIAL INSERT COULD NOT BE CONFIRMED. PATIENT BONE FRACTURE WAS CONFIRMED VIA MEDICAL RECORDS. X-RAYS WERE PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED A PERIPROSTHETIC FRACTURE LOCATED ALONG THE MEDIAL CORTEX ADJACENT TO THE SPINDLE COMPONENT OF THE TIBIA. NO SIGNS OF LOOSENING OR WEAR. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A CUSTOM LEFT KNEE PROCEDURE. SUBSEQUENTLY, PATIENT RETURNED TO THE SURGEON WITH PAIN NEAR THE JOINT. EXPLORATORY SURGERY REVEALED A FRACTURE OF THE PATIENT'S BONE ADJACENT TO THE SPINDLE. A REVISION PROCEDURE WAS SCHEDULED. WHEN THE REVISION PROCEDURE OCCURRED, THE SURGEON DETERMINED THE BONE FRACTURE WAS HEALING ADEQUATELY, AND NO INTERVENTION WAS NEEDED AROUND THE SPINDLE. INSTEAD, THE TIBIAL INSERT WAS SWAPPED DUE TO WEAR. NO FURTHER REVISIONS HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANT DATE: UNKNOWN DATE IN 2009. CONCOMITANT MEDICAL PRODUCTS: CPS SML-LRG TAPER ADAPT SET CATALOG#: CP114198 LOT#: NI, CUST OSS 9.5CM MOD PROX TIBIA CATALOG#: CP114209 LOT#: NI, LIGAMENT ANCHOR WASHER W/SCREW CATALOG#: CP160110 LOT#: NI. PMA/510K: K101475- A SIMILAR DEVICE IS CLEARED UNDER THIS 510K NUMBER. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. 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 UNDERWENT A CUSTOM LEFT KNEE PROCEDURE IN 2009. SUBSEQUENTLY, THE PATIENT UNDERWENT AN EXPLORATION SURGERY WITH PAIN NEAR THE JOINT AND REVEALED A FRACTURE OF THE PATIENT'S BONE ADJACENT TO THE SPINDLE. A REVISION PROCEDURE HAS BEEN SCHEDULED. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863099 CPS TIB SPINDLE LT 12X37X42MM PROSTHESIS, KNEE KWA ZIMMER BIOMET, INC. N/A 395600

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization| R