MITEK ACL IMPLANTS

Description of Event or Problem

AUTHOR: OH (2010) AUSTRALIA. REFERENCE: OH HL, CHEN DB, SEETO BG, MACDESSI SJ. MYCOBACTERIUM FORTUITUM INFECTION AFTER ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION USING A POLYLACTIC ACID BIOABSORBABLE SCREW: CASE REPORT. KNEE. 2010 MAR;17(2):176-8. ADDRESS: SYDNEY KNEE SPECIALISTS, SUITE 211, 203-233 NEW SOUTH HEAD ROAD, EDGECLIFF, NSW 2027, AUSTRALIA TEL.: +61 2 8307 0333; FAX: +61 2 8307 0334. E-MAIL ADDRESS: SAMUELMACDESSI@SYDNEYKNEE.COM.AU (S.J. MACDESSI). PATIENT CHARACTERISTICS: AGE: (B)(6); GENDER: FEMALE; INDEX OPERATION: ARTHROSCOPIC FOUR-STRAND AUTOLOGOUS HAMSTRING ACLR AND MEDIAL MENISCAL REPAIR; DEVICES: ENDOBUTTON + BIO-INTRAFIX; TIME OF COMPLICATION: 11 WKS. (TRAVEL TO (B)(6)); TYPE OF COMPLICATION: MYCOBACTERIUM FORTUITUM. JOINT: KNEE, DEVICE: BIO-INTRAFIX, SUTURE: - NA, OTHER DEVICES: - NA. SIGNS AND SYMPTOMS: 10 MM AREA OF DEHISCENCE IN TIBIAL WOUND WITH YELLOW EXUDATES (ERYTHROCYTE SEDIMENTATION RATE (ESR) AND C-REACTIVE PROTEIN NORMAL) NO SIGNS OF DEEP INFECTION, NO KNEE JOINT EFFUSION, RANGE OF MOTION 5° TO 90° TISSUE DAMAGE: IMAGING STUDIES: MRI (4 MO.): DIFFUSE SOFT TISSUE SWELLING AND FLUID COLLECTION AROUND THE TIBIAL SCREW AND TUNNEL (NORMAL POST-OPERATIVE HIGH INTRA-SUBSTANCE SIGNAL AND INTACT MEDIAL MENISCUS. REOPERATION (RELATED/UNRELATED): (1) WOUND DEBRIDEMENT, NO APPARENT COMMUNICATION WITH THE TIBIAL TUNNEL, (2) REMOVAL OF BIO-INTRAFIX SCREW AND SHEATH, APPLICATION OF V.A.C. DRESSING (PRESENCE OF WIDE SINUS TRACT FROM THE TIBIAL WOUND TO THE TUNNEL, CLEAR FLUID AROUND THE IMPLANT) (UNRELATED) MEDICAL TREATMENT: ORAL CEPHALEXIN, CHANGED TO AMOXICILLIN WITH CLAVULANIC ACID (ADDED ROXITHROMYCIN LATER), SWITCHED TO LINEZOLID (10 WKS.) AND MOXIFLOXACIN (6 MO.) AFTER SECOND OPERATION AND MYCOBACTERIUM TESTING. F/U TIME: 7 MO. IMAGING STUDIES: NA. OBJECTIVE OUTCOMES: FULL RANGE OF KNEE MOVEMENT. STABILITY (NEGATIVE LACHMAN¿S TEST, NEGATIVE PIVOT SHIFT TEST). FUNCTIONAL OUTCOMES: RETURN TO PIVOTING SPORTS. SUBJECTIVE OUTCOMES: NO REMAINING KNEE SYMPTOMS.

Additional Manufacturer Narrative

MITEK MEDICAL SAFETY DEPARTMENT DISCOVERED THIS PUBLISHED WHITE PAPER DETAILING A HISTORICAL EVENT IN WHICH SOME MITEK DEVICES WERE IMPLICATED. IT CANNOT BE CONFIRMED THAT THIS ISSUE HAD BEEN PREVIOUSLY REPORTED TO MITEK, SO AN ADVERSE EVENT REPORT IS BEING FILED TO DOCUMENT THE EXPERIENCE DESCRIBED IN THE ARTICLE. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.