MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 2007-02-28 for DURAMER ADVANTIM POST. STAB. TIBIAL INSERT * 1890-1212 manufactured by Wright Medical Technology, Inc..
[18824182]
Allegedly pt's leg was amputated due to infection.
Patient Sequence No: 1, Text Type: D, B5
[19001222]
Investigation is not complete. Add'l info has been requested from the user facility and the surgeon. Although several attempts have been made, a medwatch 3500a has not been rec'd from the user facility. Trends will be evaluated. This report will be amended when the investigation is complete. This is the same event as 1043534-2007-00029, 00030.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1043534-2007-00031 |
| MDR Report Key | 822855 |
| Report Source | 00,07 |
| Date Received | 2007-02-28 |
| Date of Event | 2007-01-26 |
| Date Facility Aware | 2007-01-26 |
| Device Manufacturer Date | 2002-12-01 |
| Date Added to Maude | 2007-03-06 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SUSAN ANDERSON |
| Manufacturer Street | 5677 AIRLINE RD |
| Manufacturer City | ARLINGTON TN 38002 |
| Manufacturer Country | US |
| Manufacturer Postal | 38002 |
| Manufacturer Phone | 9018674140 |
| Manufacturer G1 | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Street | 5677 AIRLINE RD |
| Manufacturer City | ARLINGTON TN 38002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DURAMER ADVANTIM POST. STAB. TIBIAL INSERT |
| Generic Name | KNEE COMPONENT |
| Product Code | KRP |
| Date Received | 2007-02-28 |
| Model Number | * |
| Catalog Number | 1890-1212 |
| Lot Number | 12235645 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 810261 |
| Manufacturer | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Address | * ARLINGTON TN * US |
| Baseline Brand Name | DURAMER ADVANTIM POST STABILIZED TIBIAL INSERT |
| Baseline Generic Name | KNEE COMPONENT |
| Baseline Catalog No | 1890-1212 |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2007-02-28 |