BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE,FIXATION,BONE

    MDR report key: 8352166 · Received February 19, 2019

    Report

    Report Number
    2939274-2019-56525
    Event Type
    Injury
    Date Received
    February 19, 2019
    Report Date
    January 28, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE: 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.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN PLATE-TRAMA/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). (B)(6) YEAR OLD MALE PATIENT WITH HETEROTOPIC OSSIFICATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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: C. ONG ET AL (2012). OUTCOMES OF OPEN REDUCTION AND INTERNAL FIXATION OF PROXIMAL HUMERUS FRACTURES MANAGED WITH LOCKING PLATES. THE AMERICAN JOURNAL OF ORTHOPEDICS. PAGE 407-412. (USA). THE PURPOSE OF THIS STUDY IS TO EVALUATE THE OUTCOMES AND COMPLICATIONS OF OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF 2-, 3-, AND 4-PART PROXIMAL HUMERUS FRACTURES USING A STANDARD MANAGEMENT PROTOCOL WITH LOCKING PLATES. FROM FEBRUARY 2003 TO JANUARY 2008, 63 PATIENTS WITH ACUTE PROXIMAL HUMERUS FRACTURES MANAGED WITH ORIF AND LOCKING PLATES WERE INCLUDED IN THIS STUDY. SIXTY-THREE ACUTE FRACTURES WERE IDENTIFIED IN 63 ADULTS (19 MEN, 44 WOMEN) MEAN AGE WAS 62 YEARS AND MEAN FOLLOW-UP WAS 19 MONTHS. THERE WERE 12 TWO-PART FRACTURES, 42 THREE-PART FRACTURES, AND 9 FOUR-PART FRACTURES. PROXIMAL HUMERUS LOCKING PLATE (SYNTHES, PAOLI, PENNSYLVANIA) WAS USED TO TREAT THE FRACTURES. PATIENTS WERE EVALUATED 1, 6, 12, 26, AND 52 WEEKS AFTER SURGERY. PATIENTS WERE FOLLOWED FOR A MINIMUM OF 12 MONTHS; WHEN CLINICALLY INDICATED, FOLLOW-UP WAS CONTINUED BEYOND 12 MONTHS. MEAN FOLLOW-UP FOR THE COHORT WAS 19 MONTHS (RANGE, 12-64 MONTHS). THE COMPLICATIONS WERE REPORTED AS FOLLOWS: (B)(6) YEAR-OLD MAN UNDERWENT RESECTION ARTHROPLASTY DUE TO AN EARLY IMPLANT FAILURE. (B)(6) YEAR OLD WOMAN HAD WOUND INFECTION, SECONDARY TO A STAPHYLOCOCCUS EPIDERMIDIS INFECTION, THAT REQUIRED IRRIGATION, DRAINAGE, AND INTRAVENOUS ANTIBIOTICS. (B)(6) YEAR-OLD MAN UNDERWENT REVISION FOR REDUCTION AND FIXATION DUE TO A DISPLACED GREATER TUBEROSITY FRAGMENT THAT WAS FOUND ON CT 1 WEEK AFTER SURGERY. THE POSTOPERATIVE COURSE WAS FURTHER COMPLICATED BY A WOUND INFECTION ((B)(6) SPECIES) THAT REQUIRED INTRAVENOUS ANTIBIOTICS AND HARDWARE REMOVAL WITH IRRIGATION AND DEBRIDEMENT. (B)(6) YEAR-OLD MAN, HAD AN INFECTED POSTOPERATIVE HEMATOMA THAT REQUIRED IRRIGATION AND DEBRIDEMENT. (B)(6) YEAR-OLD FEMALE PATIENT HAD SCREW CUTOUT AND OSTEONECROSIS BUT DID NOT REQUIRE REOPERATION. (B)(6) YEAR-OLD FEMALE PATIENT HAD OSTEONECROSIS. (B)(6) YEAR-OLD MALE PATIENT HAD HETEROTOPIC OSSIFICATION. (B)(6) YEAR-OLD MALE PATIENT HAD HARDWARE FAILURE. SEVEN PATIENTS HAD SCREWS THAT PENETRATED THE HUMERAL HEAD. FIVE OF THE 7 HAD THESE SCREWS REMOVED (ROM AND SYMPTOMS IMPROVED SIGNIFICANTLY); THE OTHER 2 WERE ASYMPTOMATIC AND DID NOT REQUIRE HARDWARE REMOVAL. (B)(6) YEAR-OLD WOMAN UNDERWENT SCREW REMOVAL DUE TO SIGNIFICANT GLENOID WEAR CAUSED BY INTRA-ARTICULAR SCREW PENETRATION. (B)(6) YEAR-OLD FEMALE PATIENT HAD SCREW CUTOUT. (B)(6) YEAR-OLD FEMALE PATIENT HAD SCREW CUTOUT. (B)(6) YEAR-OLD MALE PATIENT HAD SCREW CUTOUT. (B)(6) YEAR-OLD MALE PATIENT HAD SCREW CUTOUT. (B)(6) YEAR-OLD FEMALE PATIENT HAD SCREW CUTOUT. THIS REPORT IS FOR AN UNKNOWN SYNTHES PROXIMAL HUMERUS LOCKING PLATE. THIS REPORT IS FOR A (B)(6) YEAR OLD MALE PATIENT WITH HETEROTOPIC OSSIFICATION. THIS IS REPORT 3 OF 10 FOR (B)(4). A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143894 PLATE,FIXATION,BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention