BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: RFNA

    MDR report key: 20189461 · Received September 11, 2024

    Report

    Report Number
    8030965-2024-11157
    Event Type
    Injury
    Date Received
    September 11, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. H11 ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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 COMPLAINT IS FROM A LITERATURE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: SHAATH MK, KERR MS, HAIDUKEWYCH GJ. CLINICAL AND RADIOGRAPHIC RESULTS OF A RETROGRADE NAIL - WASHER COMBINATION VERSUS LATERAL LOCKED PLATING FOR DISTAL FEMUR FRACTURES. J ORTHOP TRAUMA. 2024 AUG 13. DOI: 10.1097/BOT.0000000000002899. EPUB AHEAD OF PRINT. PMID: 39137065. OBJECTIVE/METHODS/STUDY DATA: THE OBJECTIVE OF THIS STUDY WAS TO REPORT OUTCOMES OF THE RETROGRADE FEMORAL NAIL ADVANCED WITH LATERAL ATTACHMENT WASHER (RFNA-LAW) (SYNTHES; PAOLI, PA) COMPARED TO LATERALLY LOCKED PLATES (LLP) WHEN TREATING AO/OTA TYPE 33 DISTAL FEMORAL FRACTURES. FROM 2018-2023, FORTY-EIGHT PATIENTS (19 FEMALE) WITH A MEAN AGE OF 56 YEARS (RANGE 19-94 YEARS) WERE IN THE RFNA-LAW GROUP. FIFTY-THREE PATIENTS (29 FEMALE) WITH A MEAN AGE OF 66 YEARS (24-91 YEARS) WERE IN THE LLP GROUP. FOLLOW-UP TO UNION OR A MINIMUM OF ONE YEAR. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: CONSTRUCT RFNA PLUS LAW ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - SCREWS: NAIL LOCKING (QTY 1) - 38-YEAR-OLD OBESE MALE (BMI 36 KG/M2 ) WITH A 2-PACK PER DAY SMOKING HISTORY. HE HAD A 33C FRACTURE AND HAD BACK-OUT OF THE TWO INTERLOCKING SCREWS THROUGH THE LAW. EIGHT WEEKS AFTER THE INDEX PROCEDURE, HE HAD A REINSERTION OF THE SCREWS WITH MANIPULATION TO REGAIN FLEXION. HE HEALED THE INTRA-ARTICULAR COMPONENT BUT DEVELOPED A NONUNION OF THE METAPHYSIS. HE UNDERWENT EXCHANGE NAILING AND SUBSEQUENTLY HEALED THE METAPHYSEAL NONUNION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: RFNA(QTY 1)- 32-YEAR-OLD POLY-TRAUMATIZED PATIENT WITH A SPINAL CORD INJURY WHO HAD A 33C FRACTURE, HE UNDERWENT FIXATION AND HEALED UNEVENTFULLY. DUE TO THE SPINAL CORD INJURY, HE DEVELOPED HETEROTOPIC OSSIFICATION IN HIS QUADRICEPS MUSCLE AND UNDERWENT RESECTION WITH NO COMPLICATIONS. 85-YEAR-OLD FEMALE WITH A PERIPROSTHETIC FRACTURE THAT HAD AN EXTENSION DEFORMITY AFTER FIXATION, UNDERWENT REVISION TO DISTAL FEMORAL REPLACEMENT (B)(6)-YEAR-OLD WITH A PERIPROSTHETIC FRACTURE WHO DEVELOPED A SEPTIC NONUNION AND INFECTED TOTAL KNEE ARTHROPLASTY, UNDERWENT RESECTION OF THE TOTAL KNEE ARTHROPLASTY AND PLACEMENT OF A STATIC ANTIBIOTIC SPACER AND IS CURRENTLY UNDERGOING TREATMENT 1 PATIENT DEVELOPED A DEEP VENOUS THROMBOSIS THAT DID NOT PROGRESS TO A PULMONARY EMBOLISM. 2 PATIENTS UNDERWENT MANIPULATION UNDER ANESTHESIA FOR ARTHROFIBROSIS. - 3 PATIENTS HAD MALALIGNMENT WHEN MEASURING THE IMMEDIATE, POST-OPERATIVE A POSTERIOR DISTAL FEMORAL ANGLE (PDFA) (69°, 71°, AND 96°); NO INTERVENTION WAS NOTED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - PLATES: LOCKING ATTACHMENT (QTY 1): 32-YEAR-OLD POLY-TRAUMATIZED PATIENT WITH A SPINAL CORD INJURY WHO HAD A 33C FRACTURE, HE UNDERWENT FIXATION AND HEALED UNEVENTFULLY. DUE TO THE SPINAL CORD INJURY, HE DEVELOPED HETEROTOPIC OSSIFICATION IN HIS QUADRICEPS MUSCLE AND UNDERWENT RESECTION WITH NO COMPLICATIONS. 85-YEAR-OLD FEMALE WITH A PERIPROSTHETIC FRACTURE THAT HAD AN EXTENSION DEFORMITY AFTER FIXATION, UNDERWENT REVISION TO DISTAL FEMORAL REPLACEMENT (B)(6)-YEAR-OLD WITH A PERIPROSTHETIC FRACTURE WHO DEVELOPED A SEPTIC NONUNION AND INFECTED TOTAL KNEE ARTHROPLASTY, UNDERWENT RESECTION OF THE TOTAL KNEE ARTHROPLASTY AND PLACEMENT OF A STATIC ANTIBIOTIC SPACER AND IS CURRENTLY UNDERGOING TREATMENT 1 PATIENT DEVELOPED A DEEP VENOUS THROMBOSIS THAT DID NOT PROGRESS TO A PULMONARY EMBOLISM. 2 PATIENTS UNDERWENT MANIPULATION UNDER ANESTHESIA FOR ARTHROFIBROSIS.- 3 PATIENTS HAD MALALIGNMENT WHEN MEASURING THE IMMEDIATE, POST-OPERATIVE A POSTERIOR DISTAL FEMORAL ANGLE (PDFA) (69°, 71°, AND 96°); NO INTERVENTION WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1537197 UNK - CONSTRUCTS: RFNA ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Unknown Required Intervention