MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-19 for ELEOS TIBIAL HINGE COMPONENT 25002100E manufactured by Onkos Surgical.
[186139579]
This report is for one of three devices involved in this event, please refer to report 3013450937-2020-00033 and 3013450937-2020-00035. The device history record and sterilization batch release record were reviewed and indicated that the component involved met specification. The component was unable to be obtained for further analysis. Should additional information be obtained the report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[186139580]
The patient underwent a revision surgery due to an alleged infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013450937-2020-00034 |
| MDR Report Key | 9856369 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2017-03-21 |
| Date Added to Maude | 2020-03-19 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | CRISTINA BUTRICO |
| Manufacturer Street | 77 EAST HALSEY ROAD |
| Manufacturer City | PARSIPPANY, NJ |
| Manufacturer Country | US |
| Manufacturer Phone | 2645433 |
| Manufacturer G1 | MICROPORT ORTHOPEDIC |
| Manufacturer Street | 5677 AIRLINE ROAD |
| Manufacturer City | ARLINGTON, TN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELEOS TIBIAL HINGE COMPONENT |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | KRO |
| Date Received | 2020-03-19 |
| Model Number | 25002100E |
| Catalog Number | 25002100E |
| Lot Number | 1695197 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ONKOS SURGICAL |
| Manufacturer Address | 77 EAST HALSEY ROAD PARSIPPANY, NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-19 |