MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-06-04 for OPTETRAK HI-FLEX TIBIAL INSERT, POSTERIOR 244-23-11 manufactured by Exactech, Inc..
[4571483]
Knee revision due to tibial subsidence. This event took place outside of the united states and was discovered during active surveillance for the (b)(4) registry.
Patient Sequence No: 1, Text Type: D, B5
[12087133]
The contribution of the devices to the experience reported could not be determined as the devices were not returned for eval. Additionally, the device specific identification info was not provided, precluding a review of the device history record.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1038671-2014-00186 |
| MDR Report Key | 3877897 |
| Report Source | 07 |
| Date Received | 2014-06-04 |
| Date of Report | 2014-06-04 |
| Date of Event | 2014-04-13 |
| Date Mfgr Received | 2014-05-15 |
| Date Added to Maude | 2014-06-18 |
| 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 N.W. 66TH CT. |
| Manufacturer City | GAINESVILLE FL 32653 |
| Manufacturer Country | US |
| Manufacturer Postal | 32653 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTETRAK HI-FLEX TIBIAL INSERT, POSTERIOR |
| Generic Name | OPTETRAK HI-FLEX TIBIAL INSERT |
| Product Code | HSH |
| Date Received | 2014-06-04 |
| Catalog Number | 244-23-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EXACTECH, INC. |
| Manufacturer Address | 2320 N.W. 66TH CT. GAINESVILLE FL 32653 US 32653 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other | 2014-06-04 |