MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-04 for WASHER, BOLT, NUT, NON-SPINAL,CETALLIC manufactured by Synthes Usa.
[51224409]
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.
Patient Sequence No: 1, Text Type: N, H10
[51224410]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520274-2016-13916 |
| MDR Report Key | 5848293 |
| Date Received | 2016-08-04 |
| Date of Report | 2016-07-27 |
| Date Mfgr Received | 2016-07-27 |
| Date Added to Maude | 2016-08-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TERRY CALLAHAN |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | WASHER, BOLT, NUT, NON-SPINAL,CETALLIC |
| Product Code | NDG |
| Date Received | 2016-08-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES USA |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-08-04 |