MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-06-09 for OPTETRAK ALL POLY TIBIAL COMPONENT manufactured by Exactech, Inc..
[20299148]
Revision of knee components due to tibial loosening and a fractured anterior tibia with the insertion of a stemmed tibia. This event report was received through clinical data collection activities.
Patient Sequence No: 1, Text Type: D, B5
[20496555]
The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation. Additionally, the device specific identification information was not provided, precluding a review of the device history record.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1038671-2014-00268 |
| MDR Report Key | 3889092 |
| Report Source | 07 |
| Date Received | 2014-06-09 |
| Date of Report | 2014-06-05 |
| Date Mfgr Received | 2014-05-15 |
| Date Added to Maude | 2014-06-24 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | GRAHAM CUTHBERT |
| Manufacturer Street | 2320 NW 66TH CT. |
| Manufacturer City | GAINESVILLE FL 32653 |
| Manufacturer Country | US |
| Manufacturer Postal | 32653 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTETRAK ALL POLY TIBIAL COMPONENT |
| Generic Name | ALL POLY TIBIAL COMPONENT |
| Product Code | HSH |
| Date Received | 2014-06-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EXACTECH, INC. |
| Manufacturer Address | 2320 NW 66TH CT. GAINESVILLE FL 32653 US 32653 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2014-06-09 |