MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-07-31 for ITOTAL M57250600020 manufactured by Conformis.
[6037973]
Tibial loosening was reported for pt with a total knee implant. It was reported that the pt had a mild metal allergy. Revision surgery occurred.
Patient Sequence No: 1, Text Type: D, B5
[14221507]
Tibial loosening was reported for pt with a total knee implant. It was reported that the pt had a mild metal allergy. Revision surgery occurred. Review of the device history record indicates that the device was manufactured to specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004153240-2015-00147 |
| MDR Report Key | 4961008 |
| Report Source | 07 |
| Date Received | 2015-07-31 |
| Date of Report | 2015-07-06 |
| Date of Event | 2015-07-01 |
| Date Mfgr Received | 2015-07-06 |
| Device Manufacturer Date | 2011-10-01 |
| Date Added to Maude | 2015-08-03 |
| 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 | 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 | ITOTAL |
| Generic Name | TOTAL KNEE REPLACEMENT SYSTEM |
| Product Code | OOG |
| Date Received | 2015-07-31 |
| Catalog Number | M57250600020 |
| Device Expiration Date | 2012-03-01 |
| 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 | 2015-07-31 |