MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-31 for ATTUNE FB TIB BASE SZ 3 CEM 1506-00-003 150600003 manufactured by Depuy Ireland - 9616671.
| Report Number | 1818910-2020-09702 |
| MDR Report Key | 9902638 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-12 |
| Date of Event | 2019-12-18 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2013-08-21 |
| Date Added to Maude | 2020-03-31 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | CORK MFG & MATERIAL WAREHOUSE |
| Manufacturer Street | LOUGHBEG RINGASKIDDY |
| Manufacturer City | CORK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ATTUNE FB TIB BASE SZ 3 CEM |
| Generic Name | ATTUNE IMPLANT : KNEE TIBIAL TRAY |
| Product Code | JWH |
| Date Received | 2020-03-31 |
| Model Number | 1506-00-003 |
| Catalog Number | 150600003 |
| Lot Number | 6236673 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY IRELAND - 9616671 |
| Manufacturer Address | LOUGHBEG RINGASKIDDY CO. CORK EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-31 |