MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2015-03-24 for IUNI G2 M5722INT0600210 manufactured by Conformis.
[5758893]
Patient developed a rash following knee replacement surgery and reported testing positive for cobalt chrome allergy. Surgery is planned to remove the implant.
Patient Sequence No: 1, Text Type: D, B5
[13096597]
Patient developed a rash following knee replacement surgery and reported testing positive for cobalt chrome allergy. Surgery is planned to remove the implant. Review of the device history record indicates that the device was manufactured to specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004153240-2015-00050 |
| MDR Report Key | 4640411 |
| Report Source | 01,05 |
| Date Received | 2015-03-24 |
| Date of Report | 2015-02-26 |
| Date of Event | 2015-02-01 |
| Date Mfgr Received | 2015-02-26 |
| Device Manufacturer Date | 2013-08-01 |
| Date Added to Maude | 2015-03-31 |
| 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 | 2015-03-24 |
| Catalog Number | M5722INT0600210 |
| Device Expiration Date | 2014-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONFORMIS |
| Manufacturer Address | 28 CROSBY DRIVE BEDFORD MA 01730 US 01730 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-03-24 |