BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIO-INTRAFIX

    MDR report key: 8745218 · Received June 28, 2019

    Report

    Report Number
    1221934-2019-57470
    Event Type
    Injury
    Date Received
    June 28, 2019
    Report Date
    June 21, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY , OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: H6: PATIENT CODE 3191 USED TO CAPTURE ADDITIONAL MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL PATIENT CODES WERE ADDED.

    Description of Event or Problem · 0

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: TIANWU CHEN ET AL, 2017, ¿LONG-TERM OUTCOMES OF ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION USING EITHER SYNTHETICS WITH REMNANT PRESERVATION OR HAMSTRING AUTOGRAFTS¿ THE AMERICAN JOURNAL OF SPORTS MEDICINE, VOL. 45, NO. 12, CHINA. THE STUDY EMPHASIZES ON LONG-TERM CUMULATIVE FAILURE RATE, OF ACL RECONSTRUCTION USING EITHER SYNTHETICS WITH REMNANT PRESERVATION OR HAMSTRING AUTOGRAFTS (4-STRAND SEMITENDINOSUS AND GRACILIS TENDONS). THE PATIENTS EVALUATED ON COURSE OF THIS STUDY: TOTAL 133 PATIENTS WHO UNDERWENT ACL RECONSTRUCTION (SYNTHETICS: N = 43; HAMSTRING AUTOGRAFTS: N = 90) BETWEEN (B)(6) 2004 AND (B)(6) 2007 WERE INCLUDED. QUESTIONNAIRES (TEGNER ACTIVITY SCALE, LYSHOLM KNEE SCALE, AND INTERNATIONAL KNEE DOCUMENTATION COMMITTEE [IKDC] SUBJECTIVE FORM) WERE COMPLETED PREOPERATIVELY AND AT 6 MONTHS, 1 YEAR, 5 YEARS, AND 10 YEARS POSTOPERATIVELY. THE KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) WAS ADDITIONALLY APPLIED AT 10 YEAR FOLLOW-UP. THE PHYSICAL EXAMINATION WAS BASED ON THE 2000 IKDC FORM. THE MANUAL MAXIMUM SIDE-TO-SIDE DIFFERENCE (KT-1000 ARTHROMETER), SINGLE-HOP TEST, THIGH MUSCLE ATROPHY, AND JOINT DEGENERATION (KELLGREN AND LAWRENCE CLASSIFICATION) WERE EVALUATED. THE KAPLAN-MEIER CURVE AND LOG-RANK TEST (MANTEL-COX, 95% CI) WERE USED TO COMPARE GRAFT SURVIVORSHIP. THE EXCLUSION CRITERIA WERE: 1. ANY COMBINED LIGAMENT LESION NEEDING SURGICAL INTERVENTION; 2. CHONDRAL LESION OR DEGENERATION GRADE 3 (OUTERBRIDGE); 3. PREVIOUS KNEE SURGERY AND REVISION; 4. SUBTOTAL AND TOTAL MENISCECTOMY. THE DIAGNOSIS WAS SUPPORTED BY: 1. INJURY MECHANISM; 2. PHYSICAL EXAMINATIONS; 3. MAGNETIC RESONANCE IMAGING. THE ARTICLE DESCRIBES THE FOLLOWING PROCEDURE: ALL SURGERIES WERE PERFORMED WITH THE PATIENT UNDER ANESTHESIA AND THE LACHMAN TEST, ANTERIOR DRAWER TEST, AND PIVOT-SHIFT TEST WERE PERFORMED. . DURING ARTHROSCOPIC SURGERY, ALL COMBINED INJURIES SUCH AS MENISCUS AND/OR CHONDRAL LESIONS WERE TREATED ONCE IDENTIFIED. DURING THE ACL RECONSTRUCTION WITH HAMSTRING AUTOGRAFTS, ON THE TIBIAL SIDE, THE GRAFT WAS FIXED BY THE COMBINED APPLICATION OF A SCREW (INTRAFIX) AND/OR A SPIKED WASHER AND FEMORAL FIXATION WAS PERFORMED WITH EITHER A TITANIUM BUTTON OR A CROSS-PIN SYSTEM (RIGIDFIX). DURING THE ACL RECONSTRUCTION USING SYNTHETICS, THERE WAS NO MITEK DEVICE USED. POST OPERATIVE EXAMINATIONS WERE CONDUCTED IN AVERAGING 10 YEARS IN WHICH 111 PATIENTS WERE AVAILABLE WITH 38 (88.4%) PATIENTS (MEAN AGE, 27.6 6 9.3 YEARS; 28 MEN) WITH SYNTHETICS AND 73 (81.1%) PATIENTS (MEAN AGE, 28.6 6 8.8 YEARS; 64 MEN) WITH HAMSTRING AUTOGRAFTS. AMONG THEM, 104 PATIENTS (SYNTHETICS: N = 35 [81.4%]; HAMSTRING AUTOGRAFTS: N = 69 [76.7%]) COMPLETED SUBJECTIVE EVALUATIONS, AND 89 PATIENTS (SYNTHETICS: N = 30 [69.8%]; HAMSTRING AUTOGRAFTS: N = 59 [65.6%]) COMPLETED OBJECTIVE EVALUATIONS. FOR HAMSTRING AUTOGRAFTS AND SYNTHETICS, THE CUMULATIVE FAILURE RATES WERE 8.2% AND 7.9%, RESPECTIVELY, AND THE LOG-RANK TEST DEMONSTRATED NO SIGNIFICANT DIFFERENCE BETWEEN THE 2 KAPLAN-MEIER SURVIVAL CURVES (P = .910). AT 6 MONTHS POSTOPERATIVELY, FOR HAMSTRING AUTOGRAFTS AND SYNTHETICS, THE MEAN LYSHOLM SCORE WAS 83.0 6 7.8 AND 88.1 6 7.5, RESPECTIVELY (P \ .001); THE MEAN IKDC SCORE WAS 83.8 6 7.8 AND 86.9 6 4.5, RESPECTIVELY (P = .036); AND THE MEAN TEGNER SCORE WAS 3.7 6 1.1 AND 5.0 6 1.5, RESPECTIVELY (P \ .001). AT 1 YEAR POSTOPERATIVELY, THE MEAN TEGNER SCORE WAS 5.5 6 1.9 AND 6.5 6 2.0, RESPECTIVELY (P = .011). NO STATISTICALLY SIGNIFICANT DIFFERENCE WAS OBSERVED ON OTHER SUBJECTIVE EVALUATION FINDINGS, PHYSICAL EXAMINATION FINDINGS (OVERALL IKDC GRADE A: 45.8% OF HAMSTRING AUTOGRAFTS, 50.0% OF SYNTHETICS), SIDE-TO-SIDE DIFFERENCE (1.5 6 1.5 MM FOR SYNTHETICS, 2.4 6 2.1 MM FOR HAMSTRING AUTOGRAFTS), SINGLE-HOP TEST FINDINGS (GRADE A: 84.7% OF HAMSTRING AUTOGRAFTS, 93.3% OF SYNTHETICS), GRADE A/B THIGH MUSCLE ATROPHY (88.1% OF HAMSTRING AUTOGRAFTS, 93.3% OF SYNTHETICS), IPSILATERAL RADIOGRAPHIC OSTEOARTHRITIS (55.9% OF HAMSTRING AUTOGRAFTS, 50.0% OF SYNTHETICS), AND GRAFT SURVIVOR SHIP. THE DEVICES INVOLVED WERE: 1. SCREW (INTRAFIX) 2. TITANIUM BUTTON 3. CROSS-PIN SYSTEM (RIGIDFIX). COMPLICATIONS MENTIONED IN THE ARTICLE WERE: 1. IPSILATERAL KNEE REINJURIES(OSTEOARTHRITIS) FOR PATIENTS WITH SYNTHETIC AND HAMSTRING AUTOGRAFTS 2. CONTRALATERAL KNEE RE- INJURIES 3. GRAFT RUPTURE DUE TO RE-INJURIES. 4. DONOR SITE MORBIDITY. 5. SUPERFICIAL INFECTION

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN BIO-INTRAFIX. 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: TIANWU CHEN ET AL, 2017, ¿LONG-TERM OUTCOMES OF ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION USING EITHER SYNTHETICS WITH REMNANT PRESERVATION OR HAMSTRING AUTOGRAFTS¿ THE AMERICAN JOURNAL OF SPORTS MEDICINE, VOL. 45, NO. 12, CHINA. THE STUDY EMPHASIZES ON LONG-TERM CUMULATIVE FAILURE RATE, OF ACL RECONSTRUCTION USING EITHER SYNTHETICS WITH REMNANT PRESERVATION OR HAMSTRING AUTOGRAFTS (4-STRAND SEMITENDINOSUS AND GRACILIS TENDONS). THE PATIENTS EVALUATED ON COURSE OF THIS STUDY: TOTAL 133 PATIENTS WHO UNDERWENT ACL RECONSTRUCTION (SYNTHETICS: N = 43; HAMSTRING AUTOGRAFTS: N = 90) BETWEEN JULY 2004 AND DECEMBER 2007 WERE INCLUDED. QUESTIONNAIRES (TEGNER ACTIVITY SCALE, LYSHOLM KNEE SCALE, AND INTERNATIONAL KNEE DOCUMENTATION COMMITTEE [IKDC] SUBJECTIVE FORM) WERE COMPLETED PREOPERATIVELY AND AT 6 MONTHS, 1 YEAR, 5 YEARS, AND 10 YEARS POSTOPERATIVELY. THE KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) WAS ADDITIONALLY APPLIED AT 10 YEAR FOLLOW-UP. THE PHYSICAL EXAMINATION WAS BASED ON THE 2000 IKDC FORM. THE MANUAL MAXIMUM SIDE-TO-SIDE DIFFERENCE (KT-1000 ARTHROMETER), SINGLE-HOP TEST, THIGH MUSCLE ATROPHY, AND JOINT DEGENERATION (KELLGREN AND LAWRENCE CLASSIFICATION) WERE EVALUATED. THE KAPLAN-MEIER CURVE AND LOG-RANK TEST (MANTEL-COX, 95% CI) WERE USED TO COMPARE GRAFT SURVIVORSHIP. THE EXCLUSION CRITERIA WERE: ANY COMBINED LIGAMENT LESION NEEDING SURGICAL INTERVENTION. CHONDRAL LESION OR DEGENERATION GRADE 3 (OUTERBRIDGE). PREVIOUS KNEE SURGERY AND REVISION. SUBTOTAL AND TOTAL MENISCECTOMY. THE DIAGNOSIS WAS SUPPORTED BY: INJURY MECHANISM. PHYSICAL EXAMINATIONS. MAGNETIC RESONANCE IMAGING. THE ARTICLE DESCRIBES THE FOLLOWING PROCEDURE: ALL SURGERIES WERE PERFORMED WITH THE PATIENT UNDER ANESTHESIA AND THE LACHMAN TEST, ANTERIOR DRAWER TEST, AND PIVOT-SHIFT TEST WERE PERFORMED. . DURING ARTHROSCOPIC SURGERY, ALL COMBINED INJURIES SUCH AS MENISCUS AND/OR CHONDRAL LESIONS WERE TREATED ONCE IDENTIFIED. DURING THE ACL RECONSTRUCTION WITH HAMSTRING AUTOGRAFTS, ON THE TIBIAL SIDE, THE GRAFT WAS FIXED BY THE COMBINED APPLICATION OF A SCREW (INTRAFIX; DEPUY SYNTHES) AND/OR A SPIKED WASHER AND FEMORAL FIXATION WAS PERFORMED WITH EITHER A TITANIUM BUTTON (ENDOBUTTON; SMITH & NEPHEW) OR A CROSS-PIN SYSTEM (RIGIDFIX; DEPUY SYNTHES). DURING THE ACL RECONSTRUCTION USING SYNTHETICS, THERE WAS NO MITEK DEVICE USED. POST OPERATIVE EXAMINATIONS WERE CONDUCTED IN AVERAGING 10 YEARS IN WHICH 111 PATIENTS WERE AVAILABLE WITH 38 (88.4%) PATIENTS (MEAN AGE, 27.6 6 9.3 YEARS; 28 MEN) WITH SYNTHETICS AND 73 (81.1%) PATIENTS (MEAN AGE, 28.6 6 8.8 YEARS; 64 MEN) WITH HAMSTRING AUTOGRAFTS. AMONG THEM, 104 PATIENTS (SYNTHETICS: N = 35 [81.4%]; HAMSTRING AUTOGRAFTS: N = 69 [76.7%]) COMPLETED SUBJECTIVE EVALUATIONS, AND 89 PATIENTS (SYNTHETICS: N = 30 [69.8%]; HAMSTRING AUTOGRAFTS: N = 59 [65.6%]) COMPLETED OBJECTIVE EVALUATIONS. FOR HAMSTRING AUTOGRAFTS AND SYNTHETICS, THE CUMULATIVE FAILURE RATES WERE 8.2% AND 7.9%, RESPECTIVELY, AND THE LOG-RANK TEST DEMONSTRATED NO SIGNIFICANT DIFFERENCE BETWEEN THE 2 KAPLAN-MEIER SURVIVAL CURVES (P = .910). AT 6 MONTHS POSTOPERATIVELY, FOR HAMSTRING AUTOGRAFTS AND SYNTHETICS, THE MEAN LYSHOLM SCORE WAS 83.0 6 7.8 AND 88.1 6 7.5, RESPECTIVELY (P \ .001); THE MEAN IKDC SCORE WAS 83.8 6 7.8 AND 86.9 6 4.5, RESPECTIVELY (P = .036); AND THE MEAN TEGNER SCORE WAS 3.7 6 1.1 AND 5.0 6 1.5, RESPECTIVELY (P \ .001). AT 1 YEAR POSTOPERATIVELY, THE MEAN TEGNER SCORE WAS 5.5 6 1.9 AND 6.5 6 2.0, RESPECTIVELY (P = .011). NO STATISTICALLY SIGNIFICANT DIFFERENCE WAS OBSERVED ON OTHER SUBJECTIVE EVALUATION FINDINGS, PHYSICAL EXAMINATION FINDINGS (OVERALL IKDC GRADE A: 45.8% OF HAMSTRING AUTOGRAFTS, 50.0% OF SYNTHETICS), SIDE-TO-SIDE DIFFERENCE (1.5 6 1.5 MM FOR SYNTHETICS, 2.4 6 2.1 MM FOR HAMSTRING AUTOGRAFTS), SINGLE-HOP TEST FINDINGS (GRADE A: 84.7% OF HAMSTRING AUTOGRAFTS, 93.3% OF SYNTHETICS), GRADE A/B THIGH MUSCLE ATROPHY (88.1% OF HAMSTRING AUTOGRAFTS, 93.3% OF SYNTHETICS), IPSILATERAL RADIOGRAPHIC OSTEOARTHRITIS (55.9% OF HAMSTRING AUTOGRAFTS, 50.0% OF SYNTHETICS), AND GRAFT SURVIVOR SHIP. THE DEVICES INVOLVED WERE: SCREW (INTRAFIX; DEPUY SYNTHES). TITANIUM BUTTON (ENDOBUTTON; SMITH & NEPHEW). CROSS-PIN SYSTEM (RIGIDFIX; DEPUY SYNTHES). COMPLICATIONS MENTIONED IN THE ARTICLE WERE: IPSILATERAL KNEE REINJURIES(OSTEOARTHRITIS) FOR PATIENTS WITH SYNTHETIC AND HAMSTRING AUTOGRAFTS. CONTRALATERAL KNEE RE- INJURIES. GRAFT RUPTURE DUE TO RE-INJURIES. AS 2 SCREW RELATED PROBLEMS ARE OBSERVED IN HAMSTRING AUTOGRAFTS, THIS IS EVALUATED AS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538039 UNKNOWN BIO-INTRAFIX SOFT-TISSUE ANCHOR, BIOABSORBABLE HWC DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention