BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: TRAUMA

    MDR report key: 9363924 · Received November 22, 2019

    Report

    Report Number
    2939274-2019-62354
    Event Type
    Injury
    Date Received
    November 22, 2019
    Report Date
    November 6, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INVESTIGATION SUMMARY: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTIVE 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.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNK - SCREWS: TRAUMA/ UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. IMPLANT DATE IS UNKNOWN. (B)(4). DHR CANNOT COMPLETED BECAUSE LOT NUMBER IS UNKNOWN. 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: AILANEY, N., O'CONNELL, R., GIAMBRA, L., AND GOLLADAY, G. (2019), SUPERIOR GLUTEAL ARTERY PSEUDOANEURYSM FOLLOWING INTRAMEDULLARY NAILING OF AN ATYPICAL FEMORAL FRACTURE, BMJ CASE REPORTS, VOL. 12(10), PAGES 1-4 (USA). THIS STUDY PRESENTS A CASE REPORT OF A (B)(6) YEAR-OLD FEMALE PATIENT WITH A MEDICAL HISTORY OF OSTEOPOROSIS TREATED WITH ALENDRONATE COMPLAINED OF INCREASING LEFT HIP PAIN WITH AMBULATION. DUE TO PERSISTENT SYMPTOMS 6 WEEKS LATER, A BONE SCAN AND REPEAT X-RAYS WERE OBTAINED TO RULE OUT A STRESS FRACTURE. THE IMAGES AT THAT TIME DEMONSTRATED PROXIMAL FEMUR LATERAL CORTICAL THICKENING AND AN INCOMPLETE FRACTURE, CONSISTENT WITH A BISPHOSPHONATE-ASSOCIATED ATYPICAL FEMUR FRACTURE. THE FRACTURE WAS REPAIRED WITH ANTEGRADE FEMORAL INTRAMEDULLARY FIXATION USING A 10×380 MM INTRAMEDULLARY NAIL (TFNA, DEPUY SYNTHES) WITH A 95MM CEPHALOMEDULLARY SCREW WAS PLACED AND LOCKED WITH TWO DISTAL SCREWS. IN THE POST-ANESTHESIA CARE UNIT, THE PATIENT EXPERIENCED AN EPISODE OF SYMPTOMATIC BRADYCARDIA AND HYPOTENSION WITH SYSTOLIC BLOOD PRESSURE AS LOW AS 50 MM HG THAT REQUIRED TREATMENT WITH CRYSTALLOID FLUIDS, ATROPINE AND NOREPINEPHRINE. ON POSTOPERATIVE DAY 1, THE PATIENT RECEIVED TWO UNITS OF PACKED RED BLOOD CELLS (PRBCS) FOLLOWING A DECREASE OF HAEMOGLOBIN TO 62 G/L WITH CONTINUED SYMPTOMATIC BRADYCARDIA AND HYPOTENSION WITH A BLOOD PRESSURE OF 60/40 MM HG. ON POSTOPERATIVE DAY 3, THE PATIENT¿S HAEMOGLOBIN AGAIN DECREASED TO 65 G/L AND SHE PRESENTED WITH MODERATE LEFT THIGH EDEMA AND ECCHYMOSIS ON PHYSICAL EXAMINATION. ANOTHER UNIT OF PRBCS WAS ADMINISTERED AND HER HAEMOGLOBIN SUBSEQUENTLY INCREASED APPROPRIATELY TO 73 G/L. ON POSTOPERATIVE DAY 4, SHE CONTINUED TO HAVE INCREASED ECCHYMOSIS AND HER HAEMOGLOBIN DECREASED TO 65 G/L. SHE SUBSEQUENTLY RECEIVED ANOTHER UNIT OF PRBCS AND AGREED TO OBTAIN THE CTA. THE IMAGING DEMONSTRATED ACTIVE EXTRAVASATION OF CONTRAST FROM THE SURGICAL BED ARISING FROM THE SUPERIOR GLUTEAL BRANCHES OF THE LEFT INTERNAL ILIAC ARTERY. THE ANGIOGRAPHY REVEALED A PSEUDOANEURYSM ARISING FROM THE INFERIOR BRANCHES OF THE LEFT SGA THAT WAS IMMEDIATELY CRANIAL TO THE LEFT FEMORAL INTRAMEDULLARY NAIL. AS A RESULT OF THIS FINDING, COIL EMBOLISATION OF THE LEFT SGA AND BRANCHES FEEDING THE PSEUDOANEURYSM WAS PERFORMED. AT 4 MONTHS FOLLOW-UP, X-RAYS SHOWED EVIDENCE OF POSTOPERATIVE HETEROTOPIC OSSIFICATION, HOWEVER, SHE WAS DOING CLINICALLY WELL WITHOUT ANY HIP PAIN. AT 7 MONTHS POSTOPERATION, SHE CONTINUED TO DO WELL AND DID NOT APPEAR TO HAVE ANY LONG-TERM ADVERSE EFFECTS FROM THE SGA PSEUDOANEURYSM. THIS REPORT IS FOR A 10×380 MM INTRAMEDULLARY NAIL (TFNA, DEPUY SYNTHES) WITH A 95MM CEPHALOMEDULLARY SCREW WAS PLACED AND LOCKED WITH TWO DISTAL SCREWS. THIS IS REPORT 4 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1156498 UNK - SCREWS: TRAUMA SCREW,FIXATION,BONE HWC WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR