MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-05-15 for IUNI G2 M57220600210 manufactured by Conformis, Inc..
[5876387]
Revision surgery is planned for patient with a unicondylar knee implant due to suspected tibial component loosening.
Patient Sequence No: 1, Text Type: D, B5
[13448702]
Revision surgery is planned for patient with a unicondylar knee implant due to suspected tibial component loosening. Review of the device history record indicates that the device was manufactured to specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004153240-2015-00088 |
| MDR Report Key | 4781774 |
| Report Source | 05 |
| Date Received | 2015-05-15 |
| Date of Report | 2015-04-20 |
| Date of Event | 2015-04-01 |
| Date Mfgr Received | 2015-04-20 |
| Device Manufacturer Date | 2013-12-01 |
| Date Added to Maude | 2015-05-20 |
| 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 | KARINA SNOW |
| Manufacturer Street | 28 CROSBY DRIVE |
| Manufacturer City | BEDFORD MA 01730 |
| Manufacturer Country | US |
| Manufacturer Postal | 01730 |
| Manufacturer Phone | 7813459195 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IUNI G2 |
| Generic Name | UNICONDYLAR KNEE REPLACEMENT SYSTEM |
| Product Code | OOG |
| Date Received | 2015-05-15 |
| Catalog Number | M57220600210 |
| Device Expiration Date | 2014-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONFORMIS, INC. |
| Manufacturer Address | 28 CROSBY DRIVE BEDFORD MA 01730 US 01730 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-05-15 |