MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-02-12 for ITOTAL G2 M75250600020 manufactured by Conformis.
[20727690]
Sterile barrier of the pouch containing the femoral component was compromised. The implant was sterilized at the hosp and the case was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
[21069429]
Sterile barrier of the pouch containing the femoral component was compromised. The implant was sterilized at the hosp and the case was completed successfully. Review of the device history record indicates that the device was manufactured to spec. All processing steps were completed successfully.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004153240-2015-00022 |
| MDR Report Key | 4544477 |
| Report Source | 05 |
| Date Received | 2015-02-12 |
| Date of Report | 2015-01-19 |
| Date of Event | 2015-01-01 |
| Date Mfgr Received | 2015-01-19 |
| Device Manufacturer Date | 2015-01-01 |
| Date Added to Maude | 2015-03-24 |
| 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 DR |
| 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 G2 |
| Generic Name | TOTAL KNEE REPLACEMENT SYSTEM |
| Product Code | OOG |
| Date Received | 2015-02-12 |
| Catalog Number | M75250600020 |
| Device Expiration Date | 2015-06-01 |
| 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 DR BEFORD MA 01730 US 01730 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-12 |