BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 7596606 · Received June 13, 2018

    Report

    Report Number
    8030965-2018-54309
    Event Type
    Injury
    Date Received
    June 13, 2018
    Report Date
    May 18, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    510K: THIS REPORT IS FOR AN UNKNOWN QUANTITY OF UNKNOWN SYNTHES UNICORTICAL LOCKING SCREWS/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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: FAN JCH, KWOK KB, HUNG YW (2017). TOTAL KNEE ARTHROPLASTY IN A KNEE WITH TRIPLE DEFORMITY OF FEMUR¿TIBIA¿EXTENSOR MECHANISM. JOURNAL OF ORTHOPAEDIC SURGERY. VOLUME 26. NUMBER 1. PAGES 1-8. (HONG KONG). THIS CASE REPORT AIMS TO ELABORATE ALL THE PREOPERATIVE AND TECHNICAL DETAILS IN THE CORRECTION OF COMBINED FEMORAL, TIBIAL, AND EXTENSOR MECHANISM DEFORMITIES DURING PRIMARY TOTAL KNEE ARTHROPLASTY (TKA).THIS CASE REPORTS A (B)(6) FEMALE WHO HAD RIGHT KNEE DEFORMITY AFTER A RIGHT KNEE OPERATION AT (B)(6). SHE COMPLAINED OF BILATERAL KNEE PAIN FOR 6 YEARS AND FAILED TO RESPOND TO CONSERVATIVE TREATMENT WITH SHOE RAISE, KNEE BRACE, AND ANALGESICS. HER WALKING TOLERANCE WAS LIMITED TO 15 MIN. THE PATIENT UNDERWENT TKA WITH COMBINED MEDIAL CLOSING WEDGE FEMORAL OSTEOTOMY, NEUTRAL WEDGE VALGUS DEROTATIONAL TIBIAL OSTEOTOMY, FIBULAR OSTEOTOMY AND QUADRICEPLASTY. BECAUSE OF THE SIGNIFICANT DYSPLASIA OF FEMORAL CONDYLE AND POSSIBLE MISMATCH WITH FEMORAL CANAL CENTER, THE MEDIAL DISTAL FEMORAL CLOSING WEDGE OSTEOTOMY WAS FIXED WITH AN UNKNOWN SYNTHES TOMOFIX MEDIAL DISTAL FEMUR PLATE AND UNKNOWN SYNTHES UNICORTICAL SCREWS IN THE PRESENCE OF INTRAMEDULLARY REAMING ROD. THE TIBIAL OSTEOTOMY WAS FIXED WITH AN UNKNOWN SYNTHES 3.5MM LCP MEDIAL PROXIMAL TIBIAL PLATE AND UNKNOWN SYNTHES UNICORTICAL LOCKING SCREWS. PATIENT HAD NONWEIGHT BEARING WALKING EXERCISE ON THE NEXT DAY POST-OP AND CHANGED TO PARTIAL WEIGHT-BEARING WALKING AT THE 7TH WEEK AND THEN PROCEEDED TO FULL WEIGHT BEARING WALKING AT 3 MONTHS. AT 18 MONTHS AFTER OPERATION, SHE COULD WALK UNAIDED AND RESUMED ORIGINAL DUTY. THE HEALING ON THE MEDIAL PART UNDER THE TOMOFIX WAS SLOWER THAN THE LATERAL PART, WHERE ADDITIONAL LAG SCREWS WERE APPLIED. THERE WAS NO PROBLEM WITH HEALING OF TIBIAL OSTEOTOMY WHERE CEMENTLESS ROD AND LOCKING PLATE WERE USED. THE AUTHOR POSTULATED THAT DELAY IN HEALING WAS A RESULT OF CONFLICT OF PRINCIPLE OF FIXATION ON THE MEDIAL SIDE, WHERE CEMENTED ROD ACROSS THE OSTEOTOMY SITE DID NOT ALLOW MICROMOTION BUT TOMOFIX PLATE ENCOURAGE SECONDARY BONE HEALING BY MICROMOTION. AFTER CORRECTION OF TIBIAL PROCURVATUM DEFORMITY, TIBIAL TUBEROSITY (TT) WAS MOVED MORE DISTALLY AND POSTERIOR ARTICULAR EDGE MOVED MORE PROXIMALLY. ANTERIOR SOFT TISSUE TENSION BECAME TIGHT WHILE THE POSTERIOR TISSUE TENSION WAS LOOSE. THIS LED TO TIGHTER EXTENSION GAP AND LOOSER FLEXION GAP. THERE WAS FIBULAR IMPINGEMENT DURING THE ANGULAR CORRECTION OF TIBIA. THE PROXIMAL FIBULA AT THE LEVEL OF TIBIAL OSTEOTOMY WAS FRACTURED INTRA-OPERATIVELY WITH SUSTAINED FORCE. AT 18 MONTHS POST-OP, RIGHT KNEE ACTIVE RANGE WAS 5 DEGREE TO 85 DEGREE. THIS REPORT IS FOR UNKNOWN SYNTHES UNICORTICAL LOCKING SCREWS. THIS IS REPORT 2 OF 2 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
    437392 SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention