MAUDE Adverse Event Report: SYNTHES USA; WASHER, BOLT, NUT, NON-SPINAL,CETALLIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fungal Infection (2419)

Event Type  Injury  

Manufacturer Narrative

Date of event: chondrolysis of the tibial plateau caused by articular aspergillosis after acl autograft reconstruction: management with a fresh osteochondral allograft.The journal of bone & joint surgery, volume 93-a.Number 21 (2011).This report is for an unknown soft tissue washer/unknown quantity/unknown lot.Additional device product code: hwc.Udi: unknown part number, udi is unavailable.The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the subsequent review of the following literature article: antkowiak, t., polage, c., wiedeman, j., meehan, j., and jamali, a.(2011).Chondrolysis of the tibial plateau caused by articular aspergillosis after acl autograft reconstruction: management with a fresh osteochondral allograft.The journal of bone & joint surgery, volume 93-a.Number 21.The article is a case report of a (b)(6) athlete who underwent arthroscopically assisted anterior cruciate ligament (acl) reconstruction with the use of a quadruple hamstring autograft.The graft was fixed on the femoral side with a competitor¿s fixation device and distally with a synthes large-fragment cortical screw and soft tissue washer.The course immediately after surgery was reported to be routine, but the patient continued to have substantial medial-sided knee pain two months post-operatively.Arthroscopy was performed three months after her surgery and revealed substantial destruction of the medial tibial articular cartilage with associated damage to the medial meniscus.The patient was diagnosed with osteonecrosis of the tibial plateau, delayed degeneration of the articular cartilage due to the initial injury or surgery and idiopathic chondrolysis.At an unknown date, the patient underwent revision surgery to remove the autograft, cortical screw and washer and replace them with a hemi-tibial plateau allograft which was secured anteriorly and anteromedially with four, synthes cancellous 3.0mm cannulated screws.Post-operative cultures revealed a fungal infection and the patient was returned to the operating room for irrigation and debridement of the wound and tibial canal.The tibial tunnel was debrided and a voriconazole-impregnated calcium-sulfate paste was placed into the tunnel.The patient was also treated with iv antifungal medications for two weeks followed by 12 months of oral antifungal medication and post-operative rehabilitation.At 28 months, the patient demonstrated excellent, pain free knee motion from full extension to 140 degrees of flexion.United states.Concomitant device: smith & nephew endobutton (part # unknown, lot #unknown, quantity unknown).This is report 2 of 2 for (b)(4).This report is for an unknown soft tissue washer.

• Type of Device: WASHER, BOLT, NUT, NON-SPINAL,CETALLIC
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5848293
• MDR Text Key: 51224409
• Report Number: 2520274-2016-13916
• Device Sequence Number: 1
• Product Code: NDG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 13 YR