BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - BIOMATERIAL - CEMENT: TRAUMACEM

    MDR report key: 10551331 · Received September 17, 2020

    Report

    Report Number
    2939274-2020-04195
    Event Type
    Injury
    Date Received
    September 17, 2020
    Report Date
    August 25, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    510K: THIS REPORT IS FOR AN UNKNOWN BIOMATERIAL - CEMENT: TRAUMACEM/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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 · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: GOODNOUGH H., ET AL (2020) TROCHANTERIC FIXATION NAIL ADVANCED WITH HELICAL BLADE AND CEMENT AUGMENTATION: EARLY EXPERIENCE WITH A RETROSPECTIVE COHORT, EUROPEAN JOURNAL OF ORTHOPAEDIC SURGERY & TRAUMATOLOGY VOL., PAGES 4-6 (USA). THIS RETROSPECTIVE COHORT STUDY AIMS TO REPORT ON THE EARLY CLINICAL AND RADIOGRAPHIC OUTCOMES OF CEMENT AUGMENTATION OF CMNS IN THE TREATMENT OF GERIATRIC IT PROXIMAL FEMUR FRACTURES. FROM 2018 TO 2019, ALL IT FEMUR FRACTURES (AO/OTA 31A1-3) TREATED WITH INTERTROCHANTERIC (IT) FEMUR FRACTURES WITH A CEPHALOMEDULLARY NAIL (CMNS) WERE IDENTIFIED. SEVENTY-FIVE PATIENTS UNDERWENT CEPHALOMEDULLARY NAILING FOR IT FRACTURES. TWENTY-TWO WERE ADDITIONALLY TREATED WITH AUGMENTATION (22/75). FIFTY-THREE PATIENTS WITH CEPHALOMEDULLARY NAILS FOR IT FRACTURES HAD 3-MONTH FOLLOW-UP, INCLUDING 11/53 TREATED WITH PMMA AUGMENTATION. 11 PATIENTS (10 FEMALES, 1 MALE) AGE AT SURGERY 86.91 (75¿95) WITH IT FEMUR FRACTURES WERE TREATED WITH PMMA CEMENT-AUGMENTED CMNS WERE INCLUDED, ALONG WITH 33 PROPENSITY MATCHED CONTROLS (28 FEMALES,5 MALES) TREATED WITH TFNA WITHOUT AUGMENTATION. IN EACH CASE THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) (SYNTHES, PAOLI, PA) WITH POLYMETHYLMETHACRYLATE (PMMA) (TRAUMACEM V+ CEMENT, SYNTHES, PAOLI, PA) WAS USED. A MINIMUM OF 3-MONTH FOLLOW-UP WAS DONE. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: A CASE OF A (B)(6) YEAR OLD FEMALE IN THE AUGMENTATION GROUP WHERE HER FRACTURE WAS NOT HEALED. (THE SAME PATIENT: RADIOGRAPHIC HEALING WAS CONFIRMED IN 10 PATIENTS OF PATIENTS WITH AUGMENTATION AT 3 MONTHS POSTOPERATIVELY. THE REMAINING PATIENT HAD EVIDENCE OF CALLUS FORMATION BUT WAS LOST TO FOLLOW-UP AFTER 3 MONTHS.) ONE OF THE 3 REPEAT OPERATIONS IN THE CONVENTIONAL FIXATION GROUP FOR POST-TRAUMATIC ARTHRITIS. ONE OF THE 3 REPEAT OPERATIONS IN THE CONVENTIONAL FIXATION GROUP, FOR DEEP POSTOPERATIVE HEMATOMA. 2 NON-UNION FOR TFNA GROUP. THERE WAS NO DIFFERENCE IN COLLAPSE (SLIDING) AT THE FRACTURE SITE AT 6 WEEKS BETWEEN GROUPS. TFNA-PMMA: 4.72 (2.35¿9.26) MM ; TFNA 5.67 (2.21¿7.58) MM. ONE OF THE 3 REPEAT OPERATIONS IN THE CONVENTIONAL FIXATION GROUP, ONE FOR CUT-OUT. THERE WERE 2 RADIOGRAPHIC CUT-OUT FOR TFNA GROUP. THIS REPORT IS FOR AN UNKNOWN SYNTHES POLYMETHYLMETHACRYLATE (PMMA) (TRAUMACEM V+ CEMENT). IT CAPTURES A CASE OF A (B)(6) YEAR OLD FEMALE IN THE AUGMENTATION GROUP WHOSE FRACTURE WAS NOT HEALED. THIS IS REPORT 2 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010531 UNK - BIOMATERIAL - CEMENT: TRAUMACEM POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT LOD WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Required Intervention