MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-12-02 for WRIGHT MEDICAL FEMORAL TIBIAL CAN NOT READ manufactured by Wright Medical.
[19169625]
Total knee infection secondary to an abdominal infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 136788 |
| MDR Report Key | 136788 |
| Date Received | 1997-12-02 |
| Date of Report | 1997-10-22 |
| Date of Event | 1997-10-21 |
| Date Facility Aware | 1997-10-21 |
| Report Date | 1997-10-31 |
| Date Reported to Mfgr | 1997-10-31 |
| Date Added to Maude | 1997-12-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WRIGHT MEDICAL |
| Generic Name | TOTAL KNEE |
| Product Code | KRP |
| Date Received | 1997-12-02 |
| Model Number | FEMORAL TIBIAL |
| Catalog Number | CAN NOT READ |
| Lot Number | 1895 0014 116K057561 |
| ID Number | * |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 133628 |
| Manufacturer | WRIGHT MEDICAL |
| Manufacturer Address | 5677 AIRLINE RD. ARLINGTON TN 38002 US |
| Baseline Brand Name | DURAMER BRAND ADVANTIM ALL-POLY PATELLA |
| Baseline Generic Name | KNEE COMPONENT |
| Baseline Catalog No | 1880-0238 |
| 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 | 1997-12-02 |