MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-09-26 for OPTETRAK CC TIBIAL INSERT 208-23-13 manufactured by Exactech, Inc..
[4968475]
Revision of optetrak knee components. The surgeon had planned for a tibial insert exchange, but metal wear was noted when the knee was opened. Primary date of surgery: (b)(6) 2012.
Patient Sequence No: 1, Text Type: D, B5
[12484330]
Engineering eval noted that the revision reported was likely the result of not properly aligning the components implanted during the original surgery.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1038671-2014-00502 |
| MDR Report Key | 4213660 |
| Report Source | 99 |
| Date Received | 2014-09-26 |
| Date of Report | 2014-09-24 |
| Date of Event | 2013-09-03 |
| Date Added to Maude | 2014-11-03 |
| 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 |
| Manufacturer Phone | 8003922832 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTETRAK CC TIBIAL INSERT |
| Generic Name | TIBIAL INSERT |
| Product Code | HSH |
| Date Received | 2014-09-26 |
| Catalog Number | 208-23-13 |
| Device Availability | N |
| 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 | 2014-09-26 |