BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GII ANCHOR

    MDR report key: 9245643 · Received October 28, 2019

    Report

    Report Number
    1221934-2019-59279
    Event Type
    Injury
    Date Received
    October 28, 2019
    Report Date
    October 24, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    JDR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN. 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. CONCOMITANT MEDICAL PRODUCT: UNKNOWN. 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: TANNAST, M. ET AL. (2010), SURGICAL DISLOCATION OF THE HIP FOR THE FIXATION OF ACETABULAR FRACTURES, JOURNAL OF BONE JOINT SURGERY VOL. 92-B, PAGES 842-852 (SWITZERLAND). THE STUDY EMPHASIZES ON THE SAFETY AND POTENTIAL COMPLICATIONS RELATED TO THIS SURGICAL APPROACH IN A LARGER SERIES OF PATIENTS, TO DESCRIBE AND QUANTIFY THE INTRA-ARTICULAR DAMAGE TO THE ACETABULAR AND FEMORAL CARTILAGE WHICH WAS ONLY POSSIBLE BY ADOPTING THIS SURGICAL APPROACH, TO EVALUATE THE MID-TERM FUNCTIONAL AND RADIOLOGICAL RESULTS OF ACETABULAR FRACTURES TREATED BY SURGICAL DISLOCATION OF THE HIP WITH SPECIAL ATTENTION DIRECTED TOWARDS THE VIABILITY OF THE FEMORAL HEAD IN COMPARISON WITH THE PREVIOUS REPORTS IN THE LITERATURE AND TO IDENTIFY FACTORS ASSOCIATED WITH A POOR OUTCOME. BETWEEN MAY 1995 AND DECEMBER 2004, A TOTAL OF 54 PATIENTS WHO UNDERWENT ORIF. THEY WERE TREATED WITH BONE ANCHORS (G II TITANIUM ANCHOR; DEPUY MITEK, NORWOOD, MASSACHUSETTS), THE MEAN FOLLOW-UP WAS 4.4 YEARS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 1 PATIENT HAD SUPERIOR GLUTEAL NERVE PALSY. 1 PATIENT HAD FRACTURE PSEUDOARTHROSIS. THIS PATIENT WAS NON-COMPLIANT WITH A TRANSVERSE ACETABULAR FRACTURE WHO IGNORED WEIGHT-BEARING RESTRICTIONS AND UNDERWENT SURGICAL REVISION SIX MONTHS AFTER THE PRIMARY PROCEDURE. 1 PATIENT HAD NONUNION OF THE TROCHANTERIC OSTEOTOMY HAD OCCURRED WITHOUT CRANIAL OR ANTERIOR DISPLACEMENT. THE PATIENT'S ABDUCTOR STRENGTH REMAINED FULL AND THE MERLE D'AUBIGNE SCORE WAS 17 AT THE LAST FOLLOW-UP AT 2.5 YEARS. ACCORDINGLY, NO FURTHER ACTION WAS TAKEN. 1 PATIENT HAD LOSS OF REDUCTION OF THE FRACTURE. 1 PATIENT HAD THEIR PERINEURIUM OF THE SCIATIC NERVE IATROGENICALLY DAMAGED AND WAS IMMEDIATELY SUTURED. THE PATIENT DID NOT HAVE ANY DETECTABLE SENSORY OR MOTOR DEFICIT POST-OPERATIVELY. CLINICAL: 4 PATIENTS HAD FAIR RESULTS AND 6 PATIENTS HAD POOR RESULTS. 4 PATIENTS HAVE UNDERGONE THR. 2 PATIENTS HAD MODERATE TO SEVERE HETEROTROPIC OSSIFICATION, 1 PATIENT HAD DEHISCENCE OF THE FASCIA LATA WHICH REQUIRED REPAIR. 1 NON-COMPLIANT PATIENT PREVIOUSLY DESCRIBED DEVELOPED PSEUDARTHROSIS OF THE ACETABULUM, ONE HAD GRADE-3 ABRASIONS OF THE ENTIRE VENTRAL PORTION OF THE FEMORAL HEAD (SECTORS 1 TO 4), AND ONE WITH GRADE-2 LESIONS OF THE FEMORAL HEAD WAS REFERRED FOR CHRONIC PAIN CLINIC MANAGEMENT SINCE THE RADIOGRAPHS DID NOT DEMONSTRATE OSTEOARTHRITIS AND CLINICAL EXAMINATION WAS EQUIVOCAL AT FOLLOW-UP, TWO OF THE EIGHT PATIENTS WITH A TRAUMATIC INJURY TO THE SCIATIC NERVE HAD A RESIDUAL PERONEAL SENSORIMOTOR DEFICIT. ONLY ONE OF THOSE REQUIRED THE USE OF ADDITIONAL AIDS. RADIOLOGICAL ANALYSIS: 4 PATIENTS HAD FAIR RESULTS. ACCORDING TO THE CLASSIFICATION OF BROOKER ET AL OSSIFICATION WAS RATED AS GRADE 1 IN SEVEN PATIENTS, GRADE 2 IN FIVE, GRADE 3 IN FOUR, AND GRADE 4 IN FOUR PATIENTS. SUBSEQUENT OPERATIONS: A TOTAL OF 11 PATIENTS HAD FURTHER OPERATIONS. ALL WERE PERFORMED FOR SECONDARY OSTEOARTHRITIS WITHOUT EVIDENCE OF AVASCULAR NECROSIS OF THE FEMORAL HEAD. THE ONLY POOR OUTCOME AFTER REVISION WAS FOTMD IN THE PATIENT WITH PSEUDARTHROSIS WHO HAD UNDERGONE REVISION FOR NONUNION OF THE FRACTURE. SURVIVAL ANALYSIS: THERE WERE EIGHT FAILURES ACCORDING TO THE DEFINITIONS. THESE OCCURRED IN THE FOUR PATIENTS WHO HAD THR, THREE WITH A POOR MODIFIED MERLE D'AUBIGNE SCORE, TWO OF WHOM HAD RADIOLOGICAL PROGRESSION OF THE OSTEOARTHRITIS, AND ONE WITH MINIMALLY SYMPTOMATIC RADIOLOGICAL PROGRESSION OF OSTEOARTHRITIS. THIS REPORT IS FOR AN BONE ANCHORS (G II TITANIUM ANCHOR; DEPUY MITEK, NORWOOD, MASSACHUSETTS),

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040464 UNKNOWN GII ANCHOR SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE JDR DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention