MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-10-04 for OPTETRAK 200-04-23 manufactured by Exactech Inc.
[3911297]
Revision due to tibial loosening. Pt complaint of progressively increasing pain during ambulation. During revision, the tibial component was found to be loose and easily removed. Surgeon noted noverhang on the medial side. Although there was primarily a good cement mantle, there was limited cement close to the finned stem. This event occurred outside of the us, in (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[11161779]
Returned devices are currently undergoing engineering evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1038671-2013-00145 |
| MDR Report Key | 3409239 |
| Report Source | 07 |
| Date Received | 2013-10-04 |
| Date of Report | 2013-10-04 |
| Date of Event | 2013-09-03 |
| Date Mfgr Received | 2013-09-06 |
| Date Added to Maude | 2013-11-12 |
| 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 | MELISSA CHRISTENSEN |
| 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 |
| Generic Name | CEMENTED FINNED TIBIAL TRAY |
| Product Code | HSH |
| Date Received | 2013-10-04 |
| Returned To Mfg | 2013-09-23 |
| Catalog Number | 200-04-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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. Hospitalization; 2. Required No Informationntervention | 2013-10-04 |