MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-05-19 for BUECHEL-PAPPAS TOTAL ANKLE REPLACEMENT manufactured by Endotec Inc..
[858475]
An artificial ankle joint failure, right ankle causing large bone cysts. The patient had a total ankle joint replacement in 1998. The ankle was becoming more and more painful and swelling beginning in 2007. On three months later, the doctor who did the ankle replacement surgery, after years of silence, sent the patient a letter to come to the office and get the ankle checked. The x-rays made that day 11/2007 showed some of the problem. The patient got a second opinion and had another surgeon repair the ankle which required a complex fusion. Note that the manufacturer and the surgeon who did the original implant are one and the same. X-rays in 12/2007 and a ct scan in 01/2008 revealed large cysts on the bone and a badly worn ankle joint that was out of alignment. The ankle required lengthy surgery to remove the failed joint and cysts, graft cadaver bone and fuse the joint. Admitted to the hospital on the following month, released on three days later. The patient is still unable to walk as of the following month and may never be able to walk normally.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5006925 |
| MDR Report Key | 1047159 |
| Date Received | 2008-05-19 |
| Date of Report | 2008-04-29 |
| Date of Event | 2007-11-01 |
| Date Added to Maude | 2008-05-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BUECHEL-PAPPAS TOTAL ANKLE REPLACEMENT |
| Generic Name | ANKLE REPLACEMENT |
| Product Code | KXC |
| Date Received | 2008-05-19 |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 1016901 |
| Manufacturer | ENDOTEC INC. |
| Manufacturer Address | SOUTH ORANGE NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit | 2008-05-19 |