BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0 LACTOSORB SYSTEM 2.0 X 7 MM LACTOSORB SCREW

    MDR report key: 7651996 · Received June 29, 2018

    Report

    Report Number
    0001032347-2018-00409
    Event Type
    Injury
    Date Received
    June 29, 2018
    Date of Event
    October 4, 2017
    Report Date
    September 12, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    PMA / PMN Number
    PK992355
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THERE WAS A REVISION DUE TO PAIN AND SWELLING IN THE AREA OF WHERE THESE PARTS WERE IMPLANTED; THEREFORE THE COMPLAINT IS CONSIDERED CONFIRMED. THE SURGEON STATES THAT WHEN THE AREA WAS REVISED, IT WAS DISCOVERED THAT THE LACTOSORB PARTS WERE ALREADY RESORBED. NO PRODUCTS WERE RETURNED AND NO FUNCTIONAL TESTS OR INSPECTIONS COULD BE PERFORMED. NO X-RAYS, SCANS, PHYSICIANS REPORTS, OR ADDITIONAL PICTURES WERE PROVIDED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE INSTRUCTIONS FOR USE (IFU) STATES IN THE SECTION TITLED POSSIBLE ADVERSE EFFECTS: INFECTION CAN LEAD TO FAILURE OF THE PROCEDURE. NEUROVASCULAR INJURIES CAN OCCUR DUE TO SURGICAL TRAUMA. IMPLANTATION OF FOREIGN MATERIALS CAN RESULT IN AN INFLAMMATORY RESPONSE OR ALLERGIC REACTION. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2018-00184-2, 0001032347-2018-00185-2, 0001032347-2018-00186-2, 0001032347-2018-00407,-1 0001032347-2018-00408-1, 0001032347-2018-00410-1, AND 0001032347-2018-00411-1.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). MEDICAL PRODUCT: BIOMET MICROFIXATION 2.0 X 7 MM LACTOSORB SCREW CATALOG #: 915-2301 LOT #: 213350, BIOMET MICROFIXATION 2.0 X 7 MM LACTOSORB SCREW CATALOG #: 915-2301 LOT #: 520180, BIOMET MICROFIXATION 2.0 X 7 MM LACTOSORB SCREW CATALOG #: 915-2301-EA LOT #: 262200, BIOMET MICROFIXATION 2.0 LACTOSORB SYSTEM L-PLATE - RIGHT - REGULAR CATALOG #: 915-2101 LOT #: 013640, BIOMET MICROFIXATION 2.0 LACTOSORB SYSTEM L-PLATE - RIGHT - REGULAR CATALOG #: 915-2101 LOT #: 816200, BIOMET MICROFIXATION 2.0 LACTOSORB SYSTEM L-PLATE - LEFT - REGULAR CATALOG #: 915-2102 LOT #: 499770, AND BIOMET MICROFIXATION 2.0 LACTOSORB SYSTEM L-PLATE - LEFT - REGULAR CATALOG #: 915-2102 LOT #: 816230. THERAPY DATE: (B)(6) 2017. REPORT SOURCE: FOREIGN COUNTRY - (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, THE DEVICES WERE RESORBED INTO THE PATIENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2018-00184-1, 0001032347-2018-00185-1, 0001032347-2018-00186-1, 0001032347-2018-00407, 0001032347-2018-00408, 0001032347-2018-00410, AND 0001032347-2018-00411.

    Description of Event or Problem · 1

    IT WAS REPORTED A REVISION WAS PERFORMED DUE THE PATIENT'S COMPLAINT OF PAIN AND SWELLING. THE PATIENT COMPLAINT OF SWELLING OF THE AFFECTED PART APPROXIMATELY TEN (10) MONTHS AFTER SURGERY. THE SURGEON EXAMINED THE PATIENT AND WAS UNABLE TO CONFIRM SWELLING. AFTER TWO (2) WEEKS THE SURGEON DECIDED TO PERFORM A REVISION BECAUSE THE PATIENT COMPLAINED OF PAIN AND SWELLING OF THE AFFECTED PART AGAIN. DURING THE REVISION IT WAS IDENTIFIED THE PARTS HAD RESORBED INTO THE PATIENT'S BODY, THEREFORE NOTHING WAS REMOVED. THE POSITION OF THE IMPLANTS IS INDICATED AS THE RIGHT PYRIFORM APERTURE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493175 2.0 LACTOSORB SYSTEM 2.0 X 7 MM LACTOSORB SCREW BONE SCREW HWC BIOMET MICROFIXATION N/A 262250

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R