MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-09-15 for OPTETRAK HI-FLEX TIBIAL INSERT 244-22-13 manufactured by Exactech, Inc..
[5163055]
Revision due to pain and loosening. During revision, it was noted there was no cement mantle on femur or tibial tray.
Patient Sequence No: 1, Text Type: D, B5
[12418850]
The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation. Further, device specific info was not provided, precluding a device history record search.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1038671-2014-00429 |
| MDR Report Key | 4177441 |
| Report Source | 07 |
| Date Received | 2014-09-15 |
| Date of Report | 2014-09-11 |
| Date of Event | 2014-08-21 |
| Date Added to Maude | 2014-10-20 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTETRAK HI-FLEX TIBIAL INSERT |
| Generic Name | HI-FLEX TIBIAL INSERT |
| Product Code | HSH |
| Date Received | 2014-09-15 |
| Catalog Number | 244-22-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Required No Informationntervention | 2014-09-15 |