BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW,FIXATION,BONE

    MDR report key: 4693860 · Received April 15, 2015

    Report

    Report Number
    2520274-2015-12876
    Event Type
    Injury
    Date Received
    April 15, 2015
    Report Date
    March 20, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. DATE OF EVENT: AGUDELO,J.,MD ET AL ¿ANALYSIS OF EFFICACY AND FAILURE IN PROXIMAL HUMERUS FRACTURES TREATED WITH LOCKING PLATES¿.J ORTHOP TRAUMA 2007;21:676-681. SCREWS CUT OUT, NO ADDITIONAL SURGERY. THIS REPORT IS FOR AN UNKNOWN FOR 3.5MM STAINLESS STEEL PROXIMAL HUMERUS INTERLOCKING SYSTEM (PHILOS) UNKNOWN QUANTITY / UNKNOWN LOT. 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

    LITERATURE ARTICLE RECEIVED: THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE AGUDELO,J.,MD ET AL ¿ANALYSIS OF EFFICACY AND FAILURE IN PROXIMAL HUMERUS FRACTURES TREATED WITH LOCKING PLATES¿.J ORTHOP TRAUMA 2007;21:676-681.. USA ARTICLE AND GERMANY ARTICLE. THE PURPOSE OF THIS STUDY WAS TO DETERMINE THE EFFICACY OF PHLP AND TO IDENTIFY PREDICTORS OF LOSS OF FIXATION. OUR HYPOTHESIS WAS THAT AVOIDING VARUS REDUCTION WILL DECREASE THE EARLY MECHANICAL FAILURE RATE. A RETROSPECTIVE REVIEW WAS DONE OF PATIENTS WITH PROXIMAL HUMERUS FRACTURES TREATED WITH A PHLP BETWEEN JANUARY 1, 2001 AND JULY 31, 2005 AT 5 LEVEL 1 TRAUMA CENTERS. TWO CENTERS WERE IN THE UNITED STATES AND THE OTHER CENTERS WERE IN GERMANY. ONE HUNDRED FIFTY-THREE PATIENTS (111 FEMALE, 42 MALE) 18 YEARS OR OLDER WITH A DISPLACED FRACTURE OR FRACTURE-DISLOCATION OF THE PROXIMAL HUMERUS TREATED WITH A PROXIMAL HUMERUS LOCKING PLATE ( PHLP). THE MEAN AGE WAS 62.3 6 15.4 YEARS (22¿92). NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. TWO DIFFERENT LOCKING PLATES WERE USED IN THE STUDY: THE 3.5-MM LOCKING PROXIMAL HUMERUS PLATE (LPHP, SYNTHES, (B)(4)) OR THE 3.5-MM PROXIMAL HUMERUS INTERLOCKING SYSTEM (PHILOS; PROXIMAL HUMERUS INTERLOCKING SYSTEM, SYNTHES, (B)(4); SYNTHES, (B)(4)). ALL PATIENTS OLDER THAN 18 YEARS OF AGE WITH A DISPLACED FRACTURE OR FRACTURE-DISLOCATION OF THE PROXIMAL HUMERUS TREATED BY ORIF USING A PHLP WERE INCLUDED. THE MAIN OUTCOME MEASURE WAS LOSS OF FIXATION (INCLUDING VARUS COLLAPSE WITH OR WITHOUT INTRAARTICULAR PENETRATION OF THE SCREWS, BONE-PLATE DISENGAGEMENT, AND BREAKAGE OF THE PLATE OR SCREWS). ADDITIONAL OUTCOME MEASURES INCLUDED NONUNION (NO PROGRESSION OF RADIOGRAPHIC FRACTURE HEALING WITHIN 3 MONTHS AT ANY TIME AFTER FIXATION AND JUDGED TO REQUIRE ADDITIONAL SURGICAL TREATMENT FOR FRACTURE HEALING BY THE TREATING SURGEON), DELAYED UNION, AVASCULAR NECROSIS OF THE HUMERAL HEAD, WOUND DEHISCENCE, TUBEROSITY REDISPLACEMENT, DEEP INFECTION (INFECTION DEEP TO THE DELTOPECTORAL INTERVAL), FROZEN SHOULDER (DEFINED AS A PAINFUL RESTRICTED ACTIVE AND PASSIVE GLENOHUMERAL AND SCAPULOTHORACIC MOTION PRESENTING FOR AT LEAST 1 MONTH AFTER THE OPERATION AND NOT IMPROVING), AND SUBACROMIAL IMPINGEMENT (DEFINED AS PAIN IN THE SUBACROMIAL SPACE ON FORWARD FLEXION AND INTERNAL ROTATION OF THE HUMERUS), ROTATOR CUFF RUPTURE, SCREWS CUT-OUT. THE LPHP WAS USED IN 19.6% (N = 30) OF CASES AND THE PHILOS WAS USED IN 80.4% (N = 123) OF CASES. THE OVERALL INCIDENCE OF LOSS OF FIXATION WAS 13.7% (N = 21). AMONG FRACTURES FIXED USING THE LPHP, 13.3% (N = 4) LOST FIXATION. SIMILARLY, 13.8% (N = 17) OF FRACTURES FIXED USING THE PHILOS HAD LOSS OF FIXATION. THIS IS REPORT 13 OF 21 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN FOR 3.5MM STAINLESS STEEL PROXIMAL HUMERUS INTERLOCKING SYSTEM (PHILOS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251706 SCREW,FIXATION,BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention