BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5006604 · Received August 17, 2015

    Report

    Report Number
    2520274-2015-15175
    Event Type
    Injury
    Date Received
    August 17, 2015
    Report Date
    August 4, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    KOSKINEN, S. K. ET AL. (2014). ¿FACTORS PREDICTING THE DEVELOPMENT OF EARLY OSTEOARTHRITIS FOLLOWING LATERAL TIBIAL PLATEAU FRACTURES: MID-TERM CLINICAL AND RADIOGRAPHIC OUTCOMES OF 73 OPERATIVELY TREATED PATIENTS. SCANDINAVIAN JOURNAL OF SURGERY, (103:256-262). THIS REPORT IS FOR AN UNKNOWN L-SHAPED BUTTRESS PLATE, LISS PLATE OR L-SHAPED LCP /UNKNOWN QUANTITY/UNKNOWN LOT. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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 SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, KOSKINEN, S. K. ET AL. (2014). "FACTORS PREDICTING THE DEVELOPMENT OF EARLY OSTEOARTHRITIS FOLLOWING LATERAL TIBIAL PLATEAU FRACTURES: MID-TERM CLINICAL AND RADIOGRAPHIC OUTCOMES OF 73 OPERATIVELY TREATED PATIENTS. SCANDINAVIAN JOURNAL OF SURGERY, (103:256-262). FINLAND ARTICLE. THIS IS A RETROSPECTIVE CHART REVIEW OF SEVENTY THREE (73) PATIENTS TREATED FOR AO (THE ASSOCIATION FOR THE STUDY OF INTERNAL FIXATION) TYPE B3.1 TIBIAL PLATEAU FRACTURES AT A LEVEL I TRAUMA CENTER BETWEEN (B)(6) 2002 AND (B)(6) 2008. THIS STUDY WAS CONDUCTED TO DETERMINE WHETHER RESIDUAL ARTICULAR SURFACE DEPRESSION AND VALGUS MALALIGNMENT OF PLATED LATERAL TIBIAL PLATEAU FRACTURES AT MEDIUM-TERM FOLLOW-UP AFFECTS THE CLINICAL AND RADIOGRAPHIC OUTCOMES. ALL PATIENTS HAD PREOPERATIVE COMPUTED TOMOGRAPHY (CT) SCANS. SEVENTY-THREE (73) PATIENTS, THIRTY-TWO MALES (32) AND FORTY-ONE (41) FEMALES WITH A MEAN AGE OF FORTY-EIGHT (48) (RANGE: SEVENTEEN (17): SEVENTY-SEVEN (77)) WERE TREATED WITH PLATE FIXATION. IN TWENTY-EIGHT (28) PATIENTS A CONVENTIONAL L-SHAPED BUTTRESS PLATE WAS IMPLANTED AND IN THE REMAINING FORTY-FIVE (45) PATIENTS AN ANGULAR STABLE LOCKING PLATE, LESS INVASIVE STABILIZATION SYSTEM (LISS) PLATE OR A L-SHAPED LOCKING COMPRESSION PLATE (LCP) WAS IMPLANTED. THE STUDY FOUND THAT THERE WERE SIX (6) PATIENTS WITH A VALGUS MALALIGNMENT OF FIVE (5) DEGREES OR MORE AND THESE PATIENTS DEVELOPED MORE ADVANCED OSTEOARTHRITIS THAN PATIENTS WITH NORMAL MECHANICAL AXIS. SIMILARLY, PATIENTS (13 PATIENTS) WITH ARTICULAR DEPRESSION GREATER THAN TWO MILLIMETERS (2MM) AT FOLLOW-UP ALSO DEVELOPED MORE ADVANCED OSTEOARTHRITIS COMPARED TO PATIENTS WITH A DEPRESSION OF 2MM OR LESS. ARTICULAR SURFACE DEPRESSION OF MORE THAN 2MM WAS ALSO FOUND TO ASSOCIATED WITH MORE PAIN AT NIGHT AND PAIN WHILE SITTING AND STANDING. SIMILARLY, ARTICULAR DEPRESSION OF MORE THAN 2MM WAS ALSO ASSOCIATED WITH POORER FUNCTIONAL SCORES. THERE WERE FIVE (5) EARLY RE-OPERATIONS DUE TO POSTOPERATIVE MALREDUCTION OR LOSS OF REDUCTION. TWO (2) PATIENTS DEVELOPED COMPARTMENT SYNDROME. DESPITE FASCIOTOMY, THIS RESULTED IN SIGNIFICANT MUSCLE NECROSIS OF THE ANTERIOR COMPARTMENT DUE TO DELAYED DIAGNOSIS. ONE (1) OF THESE PATIENTS ALSO DEVELOPED DEEP INFECTION AND REQUIRED IMPLANT REMOVAL AT THREE (3) MONTHS POSTOPERATIVELY. TWO (2) PATIENTS SUSTAINED A PERMANENT PERONEAL NEUROPATHY PROBABLY DUE TO DISTENTION OF THE NERVE. THREE (3) OF THE PATIENTS SUFFERED A DEEP VEIN THROMBOSIS (DVT) DESPITE PHARMACOLOGIC PROPHYLAXIS. THIS IS REPORT 1 OF 1 FOR (B)(4) THIS REPORT IS FOR AN UNKNOWN L-SHAPED BUTTRESS PLATE, LISS PLATE OR L-SHAPED LCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541875 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention