MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-10-15 for GORE & ASSOCIATES GORTEX ANTERIOR CRUCIATE * manufactured by W.l. Gore And Associates, Inc..
[82839]
In june 1989 a gortex ligament graft was implanted by surgeon. The gortex graft failed, resulting in 4+ lochman's sign and a second degree opening of his medial joint space with valgus stressing. Also knee instability. There is migration of gortex graft material to various parts of body. There is bone erosion present due to degeneration of gortex graft.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1014752 |
| MDR Report Key | 192297 |
| Date Received | 1998-10-15 |
| Date of Report | 1998-09-03 |
| Date of Event | 1989-06-01 |
| Date Added to Maude | 1998-10-21 |
| 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 | 0 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GORE & ASSOCIATES |
| Generic Name | GORTEX LIGAMENT IN KNEE |
| Product Code | LML |
| Date Received | 1998-10-15 |
| Model Number | GORTEX ANTERIOR CRUCIATE |
| Catalog Number | * |
| Lot Number | 874202-007 |
| ID Number | 18CM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 186862 |
| Manufacturer | W.L. GORE AND ASSOCIATES, INC. |
| Manufacturer Address | PO BOX 2300 FLAGSTAFF AZ 860032800 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 1 | 1998-10-15 |