BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 7549014 · Received May 29, 2018

    Report

    Report Number
    8030965-2018-54003
    Event Type
    Injury
    Date Received
    May 29, 2018
    Report Date
    May 8, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN TOMOFIX MEDIAL DISTAL FEMUR PLATE/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INITIAL REPORTER TELEPHONE NOT AVAILABLE FOR REPORTING WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: LOBENHOFFER, P., KLEY, K. AND VAN HEERWAARDEN, R. (2017), MEDIAL CLOSED WEDGE OSTEOTOMY OF THE DISTAL FEMUR IN BIPLANAR TECHNIQUE AND A SPECIFIC PLATE FIXATOR, JOURNAL OF OPERATIVE ORTHOPADIE UND TRAUMATOLOGIE , VOL. 29, PAGES 306-319 (GERMANY) THE FOLLOWING STUDY DESCRIBES CLOSED WEDGE OSTEOTOMY OF THE DISTAL FEMUR IN BIPLANAR TECHNIQUE THAT IS GENTLE ON THE MUSCULATURE. THE SURGICAL PROCEDURE IS DESCRIBED HERE FOR VARIZATING MEDIAL CLOSED WEDGE FEMUR OSTEOTOMY, HOWEVER SIMILAR TECHNIQUE CAN ALSO BE USED AS VAGUS LATERAL CLOSED EDGE OSTEOTOMY. BETWEEN JANUARY 2005 AND OCTOBER 2008, 60 VARISATING FEMUR OSTEOTOMIES IN CLOSED-WEDGE TECHNIQUE AND WITH UNKNOWN SYNTHES TOMOFIX MEDIAL DISTAL FEMUR (MDF) WERE PERFORMED. THE STUDY CONSISTED OF 35 MALES AND 25 FEMALE PATIENTS (MEAN AGE 39.7 YEARS) SPAN OF 17-79 YEARS. THE MEAN FOLLOW-UP TIME WAS 21 MONTHS (SPAN 3-45 MONTHS). PARTIAL WEIGHT BEARING (15KG) FOR THE FIRST 4 WEEKS; X-RAY CONTROL ON DAY 3 AND 4 WEEKS AFTER SURGERY, WALKING WITHOUT CRUTCHES DEPENDING ON HEALING OF OSTEOTOMY. A SECONDARY EVALUATION WAS PERFORMED AND 107 DISTAL FEMUR OSTEOTOMIES WERE PREFORMED BETWEEN 2014 AND 2015. THE FOLLOWING COMPLICATIONS WERE REPORTED IN PATIENTS WHO UNDERWENT VARISATING FEMUR OSTEOTOMIES IN A CLOSED-WEDGE TECHNIQUE WITH TOMOFIX MDF BETWEEN JANUARY 2005 TO OCTOBER 2008 10 UNKNOWN PATIENTS COULD NOT ACHIEVE FULL EXTENSION OF THE KNEE JOINT EVEN AFTER SURGERY. 1 UNKNOWN PATIENT WITH ETHYL TOXIC LIVER DAMAGES UNDERWENT REVISION SURGERY FOR HEMATOMA RELIEF.1 PATIENT WITH SEVERE NICOTINE ABUSE WITH 50 CIGARETTES A DAY HAD PSEUDO-ARTHROSIS AND UNDERWENT REVISION SURGERY. 1 UNKNOWN PATIENT WITH LESS INTRAOPERATIVE COMPRESSION IN THE OSTEOTOMY GAP HAD PSEUDO-ARTHROSIS AND UNDERWENT REVISION SURGERY. 1 UNKNOWN PATIENT WITH HAD PSEUDO-ARTHROSIS AND UNDERWENT REVISION SURGERY. 1 UNKNOWN PATIENT HAD A SUPERFICIAL/SUBCUTANEOUS WHO UNDERWENT REVISION SURGERY. 1 PATIENT HAD A DEEP INFECTION, WHICH WAS CONTROLLED AFTER MULTIPLE REVISIONS AND FINALLY ENDED IN A KNEE-TEP. 3 UNKNOWN PATIENTS HAD DELAYED/NON-UNION OF THE OSTEOTOMY. 1 PATIENT FELL 7 WEEKS AFTER SURGERY AND SUFFERED A FRACTURE PROXIMAL TO TOMOFIX PLATE WHICH WAS TREATED THROUGH OSTEOSYNTHESIS WITH THE COMPETITOR¿S DEVICE. THE FOLLOWING COMPLICATIONS WERE REPORTED IN PATIENTS WHO UNDERWENT DISTAL FEMUR OSTEOTOMIES BETWEEN 2014 AND 2015 4 PATIENTS HAD DELAYED HEALING OF THE OSTEOTOMY, WHICH HEALED WITH SPONGIOPLASTIC SURGERY AND ADDITIVE SMALL FRAGMENT PLATE OSTEOSYNTHESIS ON THE SIDE OF ROTATION POINT OF OSTEOTOMY. A FEMALE (WEIGHT (B)(6)) EXPERIENCED PLATE BREAKAGE. A RE-OSTEOSYNTHESIS WAS PERFORMED WITH A LATERAL LISS PLATE PLUS AUTOLOGOUS SPONGIOPLASTIC SURGERY. THIS REPORT IS FOR AN UNKNOWN SYNTHES TOMOFIX MEDIAL DISTAL FEMUR (MDF) THIS IS REPORT 1 OF 3 FOR (B)(4). A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390911 PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention