BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4673470 · Received April 9, 2015

    Report

    Report Number
    2520274-2015-12364
    Event Type
    Malfunction
    Date Received
    April 9, 2015
    Report Date
    March 25, 2015
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. (B)(4). THIS REPORT IS FOR AN UNKNOWN PROXIMAL HUMERAL INTERNAL LOCKING SYSTEM. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICES WERE RETURNED AND NO LOT NUMBERS OR PART NUMBERS WERE 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 ¿DISPLACEMENT/SCREW CUTOUT AFTER OPEN REDUCTION AND LOCKED PLATE FIXATION OF HUMERAL FRACTURES.¿ GORCZYCA, J., OWSLEY, K. (2008) (COUNTRY: USA). THE PURPOSE OF THIS STUDY WAS TO ASSESS THE RADIOGRAPHIC AND CLINICAL RESULTS OF A SINGLE SURGEON¿S EXPERIENCE TREATING PROXIMAL HUMERAL FRACTURES WITH A LOCKED PROXIMAL HUMERAL PLATE. A RETROSPECTIVE STUDY WAS CONDUCTED FROM (B)(6) 2002 TO (B)(6) 2005 ON 53 PATIENTS, 41 FEMALE AND 12 MALE WITH AN AGE RANGE OF 18 TO 89 YEARS. IN ALL CASES, A LOCKING PLATE SYSTEM DESIGNED SPECIFICALLY FOR THE PROXIMAL PART OF THE HUMERUS WAS USED; FORTY-EIGHT PROXIMAL HUMERAL INTERNAL LOCKING SYSTEMS (SYNTHES, (B)(4)) WERE USED. FIFTY-TWO (98%) OF THE FIFTY-THREE FRACTURES HEALED WITHIN SIX MONTHS AFTER THE SURGERY. NINETEEN PATIENTS (36%) HAD RADIOGRAPHIC EVIDENCE OF A COMPLICATION, INCLUDING TWELVE CASES OF INTRA-ARTICULAR CUT-THROUGH BY HARDWARE, THIRTEEN CASES OF RELEVANT VARUS DISPLACEMENT (SOME WITH CONCOMITANT HARDWARE CUT-THROUGH), AND TWO CASES OF OSTEONECROSIS (ONE OF WHICH WAS ASSOCIATED WITH NONUNION). IN TWELVE PATIENTS, SCREWS HAD MOVED >3 MM THROUGH THE BONE, AND ALL OF THESE SCREWS PROTRUDED THROUGH THE SUBCHONDRAL BONE. IN PATIENTS OLDER THAN SIXTY YEARS OF AGE, THE PREVALENCE OF CUTOUT WAS NINE (43%) OF TWENTY-ONE. THIS PREVALENCE WAS NOT RELATED TO FRACTURE TYPE, AS FOUR OF THE EIGHT TWO-PART FRACTURES HAD CUTOUT AND FIVE OF THE THIRTEEN THREE OR FOUR-PART FRACTURES HAD CUTOUT IN THIS AGE-GROUP. HOWEVER, IN THIS AGE GROUP, THREE OF THE FIVE PATIENTS WITH A THREE OR FOUR-PART FRACTURE AND CUTOUT HAD REVISION SURGERY WHEREAS NONE OF THE FOUR PATIENTS WITH A TWO-PART FRACTURE AND CUTOUT HAD REVISION SURGERY. ONE PATIENT WITH SUBSTANTIAL VARUS DISPLACEMENT HAD IMPINGEMENT SYMPTOMS ONE YEAR AFTER THE FRACTURE HAD HEALED. A PATIENT WHO DID NOT COMPLY WITH INSTRUCTIONS AND RETURNED TO PERFORMING STRENUOUS LABOR THREE WEEKS POSTOPERATIVELY HAD TWO SCREWS CUT OUT; THE SCREWS WERE EXCHANGED FOR SHORTER SCREWS THAT DID NOT PROTRUDE INTO THE JOINT, AND THE FRACTURE HEALED WELL WITHOUT SCREW CUTOUT. A PROXIMAL HUMERAL HEMIARTHROPLASTY WAS PERFORMED IN TWO PATIENTS; IT WAS DONE BECAUSE OF OSTEONECROSIS WITH INTRA-ARTICULAR SCREWS IN ONE AND BECAUSE OF ADVANCED OSTEONECROSIS WITH A DEGENERATED JOINT, NONUNION, AND INTRAARTICULAR SCREWS IN THE OTHER. SIX PATIENTS WITH INTRA-ARTICULAR SCREWS OPTED NOT TO HAVE REVISION SURGERY AND WERE ABLE TO MAINTAIN A COMFORTABLE LIFESTYLE WITH SCREWS THAT PROTRUDED PREDOMINANTLY ANTERIORLY AND INFERIORLY INTO THE GLENOHUMERAL JOINT. THERE WERE NO RADIOGRAPHIC SIGNS OF BREAKAGE OF ANY SCREWS OR PLATES. NONE OF THE LOCKING SCREWS APPEARED TO UNLOCK OR LOOSEN FROM THE PLATE. ONE PATIENT WITHOUT RADIOGRAPHIC SIGNS OF A COMPLICATION DIED FROM A MEDIASTINAL TUMOR SEVEN MONTHS POSTOPERATIVELY. THIS REPORT IS FOR AN UNKNOWN PROXIMAL HUMERAL INTERNAL LOCKING SYSTEM. THIS IS REPORT 4 OF 19 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237454 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention