MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2000-06-20 for ADVANTIM SMOOTH TIBIAL STEM 1872-0613 manufactured by Wright Medical Technology, Inc..
| Report Number | 1043534-1999-00085 |
| MDR Report Key | 285078 |
| Report Source | 06,07 |
| Date Received | 2000-06-20 |
| Date of Event | 1999-08-30 |
| Date Mfgr Received | 1999-08-31 |
| Device Manufacturer Date | 1998-04-01 |
| Date Added to Maude | 2000-07-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DEBBY DAURER |
| Manufacturer Street | 5677 AIRLINE RD |
| Manufacturer City | ARLINGTON TN 38002 |
| Manufacturer Country | US |
| Manufacturer Postal | 38002 |
| Manufacturer Phone | 9018674601 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVANTIM SMOOTH TIBIAL STEM |
| Generic Name | KNEE COMPONENT |
| Product Code | KRP |
| Date Received | 2000-06-20 |
| Model Number | NA |
| Catalog Number | 1872-0613 |
| Lot Number | 048A000741 |
| ID Number | NA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 233930 |
| Manufacturer | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Address | 5677 AIRLINE RD ARLINGTON TN 38002 US |
| Baseline Brand Name | ADVANTIM SMOOTH TIBIAL STEM |
| Baseline Generic Name | KNEE COMPONENT |
| Baseline Catalog No | 1872-0613 |
| Baseline Device Family | K J 888.3560 |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-06-20 |