MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-23 for IDUO G2 BKA-111-1111 manufactured by Conformis, Inc..
[176213831]
It was reported that the patient had post-op loosening of the tibial baseplate. The patient's knee was revised to an off-the-shelf implant by a non-conformis surgeon. Review of the device history record indicates that the device was manufactured to specification.
Patient Sequence No: 1, Text Type: N, H10
[176213832]
It was reported that the patient had post-op loosening of the tibial baseplate. The patient's knee was revised to an off-the-shelf implant by a non-conformis surgeon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004153240-2020-00019 |
| MDR Report Key | 9623864 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-23 |
| Date of Report | 2020-01-23 |
| Date of Event | 2019-08-26 |
| Date Mfgr Received | 2020-01-09 |
| Device Manufacturer Date | 2018-12-31 |
| Date Added to Maude | 2020-01-23 |
| 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 | EMMANUEL NYAKAKO |
| Manufacturer Street | 600 TECHNOLOGY PARK DRIVE |
| Manufacturer City | BILLERICA MA 01821 |
| Manufacturer Country | US |
| Manufacturer Postal | 01821 |
| Manufacturer Phone | 7813459164 |
| Manufacturer G1 | CONFORMIS, INC. |
| Manufacturer Street | 600 RESEARCH DRIVE |
| Manufacturer City | WILMINGTON MA 01887 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01887 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IDUO G2 |
| Generic Name | BICOMPARTMENTAL KNEE REPLACEMENT SYSTEM |
| Product Code | NPJ |
| Date Received | 2020-01-23 |
| Catalog Number | BKA-111-1111 |
| 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 | 600 TECHNOLOGY PARK DRIVE BILLERICA MA 01821 US 01821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-23 |