BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: PLATE/SCREWS

    MDR report key: 10756703 · Received October 29, 2020

    Report

    Report Number
    8030965-2020-08352
    Event Type
    Injury
    Date Received
    October 29, 2020
    Report Date
    October 2, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN SYNTHES LESS INVASIVE STABILIZATION SYSTEM (LISS-DF) PLATE/SCREW CONSTRUCT/UNKNOWN LOT. PART AND LOT NUMBERS 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. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: MA C., ET AL (2019) PLATE-ON-PLATE TECHNIQUE FOR TREATING PERI-IMPLANT FRACTURES OF DISTAL FEMORAL LOCKING PLATE: A RETROSPECTIVE STUDY OF 11 PATIENTS, ARCHIVES OF ORTHOPAEDIC AND TRAUMA SURGERY, VOLUME 139, PAGES 1245¿1251 (TAIWAN). THIS RETROSPECTIVE STUDY AIMS TO INVESTIGATE THE FEASIBILITY AND RELIABILITY OF USING A PLATE-ON-PLATE TECHNIQUE FOR TREATING THESE DIFFICULT CASES. FROM JANUARY 2008 TO DECEMBER 2016, 437 PATIENTS WITH 440 DISTAL FEMORAL FRACTURES WERE TREATED WITH A DISTAL FEMUR LOCKING PLATE (A LISS-DF OR ZPLP-DF). LESS INVASIVE STABILIZATION SYSTEM (LISS-DF; SYNTHES, PAOLI, PA, USA) USED IN SIX CASES AND A ZPLP-DF (ZIMMER, WARSAW, INDIA, USA) USED IN FIVE CASES FOR ORIGINAL DISTAL FEMORAL FRACTURE. OF THESE, 28 DEVELOPED A PERI-IMPLANT FRACTURE AT THE OUTERMOST PROXIMAL LOCKING SCREW. 11 PATIENTS (7 FEMALES, 4 MALES) AVERAGE AGE WAS 66.5 (RANGING FROM 22 TO 86) YEARS WITH UNHEALED DISTAL FEMORAL FRACTURE WHO WERE TREATED WITH THE PLATE-ON-PLATE TECHNIQUE USING A NON- CONTACT BRIDGING-PERIPROSTHETIC PLATE (NCB-PP ZIMMER INC., WINTERTHUR, SWITZERLAND) OR A DISTAL FEMORAL LOCKING PLATE THAT WAS DESIGNED FOR TREATING DISTAL FEMORAL FRACTURES (LISS-DF OR ZPLP-DF) WERE ENROLLED IN THE STUDY. THE PATIENTS WERE FOLLOWED UP FOR A MINIMUM PERIOD OF 1 YEAR WITH AN AVERAGE DURATION OF 20.5 (RANGE 15¿30) MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 28 DEVELOPED A PERI-IMPLANT FRACTURE AT THE OUTERMOST PROXIMAL LOCKING SCREW. (AMONG THE 440 DISTAL FEMORAL FRACTURES THAT WERE TREATED WITH PREVIOUS DISTAL FEMORAL LOCKING PLATE SYSTEM (A LISS-DF OR ZPLP-DF). UNION WAS DELAYED IN ONE SUBTROCHANTERIC AREA FRACTURE. (AFTER SECOND SURGERY). A CASE OF A 68 YEAR OLD FEMALE (CASE 1) INITIALLY TREATED WITH LISS HAD PERI-IMPLANT FRACTURE (AO/OTA 32-A1) IN THE OUTERMOST SCREW HOLE OF THE LOCKING PLATE AND UNHEALED ORIGINAL DISTAL FEMORAL FRACTURE .PATIENT UNDERWENT AND PLATE-ON-PLATE TECHNIQUE USING LISS. A CASE OF AN (B)(6) YEAR OLD FEMALE (CASE 2) INITIALLY TREATED WITH LISS HAD PERI-IMPLANT FRACTURE (AO/OTA 32-A1) IN THE OUTERMOST SCREW HOLE OF THE LOCKING PLATE AND UNHEALED ORIGINAL DISTAL FEMORAL FRACTURE. PATIENT UNDERWENT PLATE-ON-PLATE TECHNIQUE USING LISS HAD HIP LATERAL ASPECT PAIN DUE TO PLATE PROMINENCE (CONTRALATERAL LISS-DISTAL FEMUR). IT DID NOT RESTRICT THE PATIENTS¿ DAILY ACTIVITIES AND COULD BE CONTROLLED WITH ORAL PAIN KILLERS. A CASE OF A (B)(6) YEAR OLD FEMALE (CASE 3)INITIALLY TREATED WITH LISS HAD PERI-IMPLANT FRACTURE (AO/OTA 32-A1) IN THE OUTERMOST SCREW HOLE OF THE LOCKING PLATE AND UNHEALED ORIGINAL DISTAL FEMORAL FRACTURE. PATIENT UNDERWENT PLATE-ON-PLATE TECHNIQUE USING LISS HAD HIP LATERAL ASPECT PAIN DUE TO PLATE PROMINENCE (CONTRALATERAL LISS-DISTAL FEMUR). IT DID NOT RESTRICT THE PATIENTS¿ DAILY ACTIVITIES AND COULD BE CONTROLLED WITH ORAL PAIN KILLERS. A CASE OF A (B)(6) YEAR OLD FEMALE (CASE 6) INITIALLY TREATED WITH LISS HAD PERI-IMPLANT FRACTURE (AO/OTA 32-A1) IN THE OUTERMOST SCREW HOLE OF THE LOCKING PLATE AND UNHEALED ORIGINAL DISTAL FEMORAL FRACTURE .PATIENT UNDERWENT AND PLATE-ON-PLATE TECHNIQUE USING LISS. A CASE OF A (B)(6) YEAR OLD MALE (CASE 8) INITIALLY TREATED WITH LISS HAD PERI-IMPLANT FRACTURE (AO/OTA 32-A1) IN THE OUTERMOST SCREW HOLE OF THE LOCKING PLATE AND UNHEALED ORIGINAL DISTAL FEMORAL FRACTURE .PATIENT UNDERWENT AND PLATE-ON-PLATE TECHNIQUE USING NCB-PPS NON-CONTACT BRIDGING PERIPROSTHETIC PLATE SYSTEM (ZIMMER). A CASE OF A (B)(6) YEAR OLD MALE (CASE 9) INITIALLY TREATED WITH LISS HAD PERI-IMPLANT FRACTURE (AO/OTA 32-A1) IN THE OUTERMOST SCREW HOLE OF THE LOCKING PLATE AND UNHEALED ORIGINAL DISTAL FEMORAL FRACTURE .PATIENT UNDERWENT AND PLATE-ON-PLATE TECHNIQUE USING NCB-PPS NON-CONTACT BRIDGING PERIPROSTHETIC PLATE SYSTEM (ZIMMER). THIS IS REPORT 8 OF 9 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN SYNTHES LESS INVASIVE STABILIZATION SYSTEM (LISS-DF) PLATE/SCREW CONSTRUCT (CASE 8-65 YEAR OLD MALE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1220604 UNK - CONSTRUCTS: PLATE/SCREWS PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention