MAUDE Adverse Event Report: DEPUY MITEK MITEK ACL IMPLANTS

Catalog Number UNK INTRAFIX

Device Problem Unknown (for use when the device problem is not known) (2204)

Patient Problem Surgical procedure, repeated (2042)

Event Type  Injury  

Event Description

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.

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.

• Brand Name: MITEK ACL IMPLANTS
• Type of Device: ACL IMPLANTS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; quality department; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; na; raynham MA 02767
• Manufacturer Contact: siri belur ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 3759966
• MDR Text Key: 4485688
• Report Number: 1221934-2014-00144
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK INTRAFIX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/31/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/31/2014
• Initial Date FDA Received: 04/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 15 YR