BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TM ANKLE XL POLY INSERTS

    MDR report key: 7544044 · Received May 25, 2018

    Report

    Report Number
    0001822565-2018-02870
    Event Type
    Injury
    Date Received
    May 25, 2018
    Date of Event
    January 1, 2017
    Report Date
    December 3, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSN
    PMA / PMN Number
    PK120906
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H10: RELATED REPORT NUMBERS: 0001822565-2018-01359-2. 0001822565-2018-01360-2. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT ANKLE ARTHROPLASTY APPROXIMATELY TEN (10) YEARS AND SEVEN (7) MONTHS AGO. SUBSEQUENTLY, THE PATIENT REPORTED APPROXIMATELY TWO (2) YEARS AND TWO (2) MONTHS AFTER THE INITIAL SURGERY THE PATIENT COMPLAINED OF MODERATE SWELLING, STIFFNESS, AND PAIN WHICH LEAD TO A FINDING OF HETEROTOPIC OSSIFICATION. NO TREATMENT WAS PROVIDED AND THE PATIENT REPORTED SATISFACTION WITH THEIR ANKLE.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. X-RAY REVIEWER STATED SUBTALAR AND MIDFOOT FUSION. BONY FUSION IS NOTED ALONG THE MEDIAL AND LATERAL ANKLE SECONDARY TO HETEROTOPIC OSSIFICATION. MILD BIMALLEOLAR ANKLE SOFT TISSUE SWELLING. OSTEOPENIA. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT INITIAL ANKLE PROCEDURE APPROXIMATELY FOUR YEARS PRIOR. SUBSEQUENTLY, PATIENT UNDERWENT OBSERVATION FOR HETEROTOPIC OSSIFICATION TREATMENT. IT WAS ALSO REPORTED THE PATIENT SUFFERS FROM PAIN, SWELLING, AND LIMITED RANGE OF MOTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386590 TM ANKLE XL POLY INSERTS KNEE PROSTHESIS HSN ZIMMER BIOMET, INC. N/A 62637225

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Other SEE H10.