BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: PHILOS PLATE/SCREWS

    MDR report key: 15116991 · Received July 27, 2022

    Report

    Report Number
    8030965-2022-05301
    Event Type
    Injury
    Date Received
    July 27, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. THIS REPORT IS FOR AN UNKNOWN DEVICE/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DEVICE AVAILABLE FOR EVALUATION: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE EVALUATED BY MFR AND MANUFACTURE DATE: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR 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.

    Description of Event or Problem · 0

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: HAZRA, R.O.D., ET AL. (2022), MINIMUM 2-YEAR RESULTS OF THE SECOND-GENERATION CFR-PEEK LOCKING PLATE ON THE PROXIMAL HUMERAL FRACTURE, EUROPEAN JOURNAL OF ORTHOPAEDIC SURGERY & TRAUMATOLOGY, VOL. XX, PAGES 1-8 (GERMANY). THE AIM OF THIS STUDY WAS TO ANALYSE AND COMPARE THE 24-MONTH RANGE OF MOTION RESULTS OF PATIENTS TREATED WITH CFR-PEEK2 VERSUS CONVENTIONAL TITANIUM PLATE OSTEOSYNTHESES (TAL-P). BETWEEN NOVEMBER 2016 AND APRIL 2018, A TOTAL OF 30 PATIENTS WERE TREATED WITH CFR-PEEK (PEEK POWER PLATE, ARTHREX, NAPLES, FL, USA) WHILE 35 PATIENTS (MEAN AGE OF 68.1 (RANGE 42¿89) YEARS AND A SEX-DISTRIBUTION OF 26 FEMALE AND NINE MALE PATIENTS) WERE TREATED WITH THE CONVENTIONAL T-PAL (TITANIUM ALLOY LOCKING PLATE (PHILOS PLATE, DEPUY SYNTHES, UMKIRCH, GERMANY)). PATIENTS UNDERWENT THE FIRST CLINICAL FOLLOW-UP AT A MINIMUM OF 24 MONTHS AFTER SURGERY. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 3 PATIENTS DIED (IT WASN'T SPECIFIED WHICH DEVICE WAS USED FOR THESE PATIENTS) PHILOS: A 61-YEAR-OLD MALE PATIENT WHO WAS TREATED FOR A 4-PART, VARUS-IMPACTED PHF PRESENTED WITH HUMERAL HEAD NECROSIS 4 WEEKS POST-OPERATIVELY AND REVISION SURGERY USING A REVERSE SHOULDER ARTHROPLASTY. AN 81-YEAR-OLD FEMALE WITH A VALGUS-IMPACTED, 4-PART PHF THAT PRESENTED WITH PARTIAL HUMERAL HEAD NECROSIS 4 WEEKS AFTER PRIMARY SURGERY AND REQUIRED REVERSE SHOULDER ARTHROPLASTY. A 52-YEAR-OLD FEMALE WITH A 4-PART, VALGUS-IMPACTED PHF WITH HUMERAL HEADSPLIT, THAT SHOWED HUMERAL HEAD NECROSIS 15 MONTHS POST-OPERATIVELY. THIS NECESSITATED A SWITCH TO AN ANATOMIC SHOULDER ARTHROPLASTY. A 79-YEAR-OLD FEMALE PATIENT WITH A 4-PART, VARUS-DISTRACTED PHF WITH A MULTI-FRAGMENTED MAJOR TUBERCLE FRACTURE PRESENTED WITH SCREW PERFORATION IN THE POST-OPERATIVE X-RAY FOLLOW-UP, NECESSITATING REVISION SURGERY TO CHANGE THE SINGULAR SCREW. THIS REPORT IS FOR UNK - CONSTRUCTS: PHILOS PLATE/SCREWS. THIS IS REPORT 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2440124 UNK - CONSTRUCTS: PHILOS PLATE/SCREWS PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention