MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2004-01-07 for FEM COMP ROT/HINGED KNEE RIGHT 6475-3-932 manufactured by Stryker Howmedica Osteonics.
[17766902]
It was reported "pt fell and experienced pain. X-rays showed a broken stem in the femoral component. The distal femoral component was resected and replaced with a new distal femur. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2249697-2004-00002 |
| MDR Report Key | 521842 |
| Report Source | 07 |
| Date Received | 2004-01-07 |
| Date of Report | 2003-12-11 |
| Date Mfgr Received | 2003-12-11 |
| Date Added to Maude | 2004-04-26 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JANICE PEVIDE |
| Manufacturer Street | 300 COMMERCE COURT |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | MAHWAH |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FEM COMP ROT/HINGED KNEE RIGHT |
| Generic Name | IMPLANT |
| Product Code | LGE |
| Date Received | 2004-01-07 |
| Model Number | NA |
| Catalog Number | 6475-3-932 |
| Lot Number | SDYVA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 510969 |
| Manufacturer | STRYKER HOWMEDICA OSTEONICS |
| Manufacturer Address | 300 COMMERCE CT MAHWAH NJ 07430 US |
| Baseline Brand Name | KINEMATIC KNEE FEMORAL COMPONENT |
| Baseline Generic Name | ARTIFICIAL KNEE COMPONENT |
| Baseline Model No | NA |
| Baseline Catalog No | 6475-3-932 |
| Baseline ID | NA |
| Baseline Device Family | KINEMATIC |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K792089 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-01-07 |