BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW,FIXATION,BONE

    MDR report key: 8289805 · Received January 30, 2019

    Report

    Report Number
    8030965-2019-60491
    Event Type
    Injury
    Date Received
    January 30, 2019
    Report Date
    January 17, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR UNKNOWN SCREWS. PART#, LOT# AND UDI # IS NOT AVAILABLE. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THIS REPORT IS FOR UNKNOWN SCREWS. PMA/510(K) NUMBER IS NOT AVAILABLE. PRODUCT WAS NOT RETURNED. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: GARCÍA-FERNÁNDEZ, C. ET AL (2018), REVERSE TOTAL SHOULDER ARTHROPLASTY FOR THE TREATMENT OF FAILED FIXATION IN PROXIMAL HUMERAL FRACTURES, INJURY-INTERNATIONAL JOURNAL OF THE CARE OF THE INJURED, VOL. 49(S2), PAGES S22-S26 (SPAIN). THE PURPOSE OF THIS RETROSPECTIVE STUDY IS TO ASSESS CLINICAL AND RADIOLOGICAL OUTCOMES AFTER RTSA AS A REVISION PROCEDURE FOR FAILED FIXATION OF DISPLACED PHF. BETWEEN 2003 AND 2016, A TOTAL OF 6 FEMALE PATIENTS WITH A MEAN AGE OF 74.4 YEARS (RANGE, 71-78 YEARS) WERE INCLUDED IN THE STUDY. OF THESE PATIENTS, 1 PATIENT WAS EXCLUDED DUE TO DEATH, 3 PATIENTS UNDERWENT REVISION USING COMPETITOR¿S DEVICE AND 2 PATIENTS UNDERWENT REVISION USING UNKNOWN SYNTHES PHILOS PLATE. DELTA XTEND REVERSE SHOULDER SYSTEM PROSTHESES CEMENTED (DEPUY, WARSAW, IN, USA) WAS USED FOR REVERSE TOTAL SHOULDER ARTHROPLASTY (RSTA) FOLLOWING FAILED INTERNAL FIXATION OF PROXIMAL HUMERAL FRACTURE (PHF). RADIOGRAPHIC ASSESSMENT WITH A STANDARD 2-VIEW (ANTEROPOSTERIOR AND LATERAL SCAPULAR ¿Y¿) WAS PERFORMED AT 1, 3, 6, 12 MONTHS AND THEN EVERY YEAR POSTOPERATIVELY. THE MEAN TIME BETWEEN INITIAL FIXATION AND RTSA WAS 12 MONTHS (RANGE, 1-31 MONTHS) AND THE MEAN FOLLOW-UP AFTER RTSA WAS 77.4 MONTHS (RANGE, 63-94 MONTHS). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOW: A (B)(6) YEAR-OLD WOMAN HAD HUMERAL NECROSIS WITH SCREW CUT-OUT. THIS PATIENT WAS REVISED BECAUSE JOINT STIFFNESS CHANGING THE DELTA XTEND GLENOID COMPONENT OF 38 STANDARD TO 42 ECCENTRIC. THIS PATIENT WAS DISSATISFIED BECAUSE ALTHOUGH THE PAIN DECEASED, HER PREOPERATIVE FUNCTIONAL STATUS DID NOT IMPROVE. A (B)(6) YEAR-OLD WOMAN HAD AVASCULAR NECROSIS OF THE HUMERAL HEAD AND HARDWARE PROTRUSION. ANOTHER UNKNOWN PATIENT HAD SHOULDER JOINT STIFFNESS TOO, BUT AS SHE IMPROVED HER SHOULDER PAIN, SHE DECLINED FURTHER REVISION SURGERY. THE ARTICLE DID NOT SPECIFY WHAT DEVICE WAS USED DURING FIXATION WHETHER A PHILOS PLATE OR FROM A COMPETITOR¿S DEVICE. 1 PATIENT EXCLUDED DUE TO DEATH. THIS REPORT IS FOR AN UNKNOWN SCREWS. IT CAPTURE THE REPORTED (B)(6) YEAR-OLD WOMAN WHO HAD HUMERAL NECROSIS WITH SCREW CUT-OUT WITH PREOPERATIVE FUNCTIONAL STATUS DID NOT IMPROVE. THIS IS REPORT 1 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80839 SCREW,FIXATION,BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention