MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2004-04-23 for KINEMATIC ROTATING HINGE TIBIAL COMPONENT 6475-3-933 manufactured by Stryker Orthopaedics.
[17026602]
Pt twisted their knee and heard a crack in their knee. Revision surgery was required to replace the tibial component.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2249697-2004-00049 |
| MDR Report Key | 522056 |
| Report Source | 01,07 |
| Date Received | 2004-04-23 |
| Date of Report | 2004-03-25 |
| Date of Event | 2004-02-27 |
| Date Mfgr Received | 2004-03-25 |
| Date Added to Maude | 2004-04-27 |
| 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 | KINEMATIC ROTATING HINGE TIBIAL COMPONENT |
| Generic Name | IMPLANT |
| Product Code | LGE |
| Date Received | 2004-04-23 |
| Model Number | NA |
| Catalog Number | 6475-3-933 |
| Lot Number | FXXHD |
| ID Number | 99316 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 511186 |
| Manufacturer | STRYKER ORTHOPAEDICS |
| Manufacturer Address | 325 CORPORATE DR. MAHWAH NJ 07430 US |
| Baseline Brand Name | TIB/BEARING COMP ROT/HIN KNEE |
| Baseline Generic Name | ARTIFICAL KNEE COMPONENT |
| Baseline Model No | NA |
| Baseline Catalog No | 6475-3-933 |
| Baseline ID | NA |
| Baseline Device Family | TIBIAL BEARING |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K811630 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-04-23 |