MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-18 for IBALANCE PATELLA IMPLANT DOME, 34 X 9 MM AR-504-PSC9 manufactured by Arthrex, Inc..
| Report Number | 1220246-2019-01365 |
| MDR Report Key | 9207325 |
| Date Received | 2019-10-18 |
| Date of Report | 2019-10-18 |
| Date of Event | 2019-09-19 |
| Date Mfgr Received | 2019-09-27 |
| Device Manufacturer Date | 2014-12-11 |
| Date Added to Maude | 2019-10-18 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | VIK BAJNATH |
| Manufacturer Phone | 8009337001 |
| Manufacturer G1 | ARTHREX, INC. |
| Manufacturer Street | 1370 CREEKSIDE BOULEVARD |
| Manufacturer City | NAPLES FL 341081945 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 341081945 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | IBALANCE PATELLA IMPLANT DOME, 34 X 9 MM |
| Generic Name | PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER |
| Product Code | KRR |
| Date Received | 2019-10-18 |
| Model Number | IBALANCE PATELLA IMPLANT DOME, 34 X 9 MM |
| Catalog Number | AR-504-PSC9 |
| Lot Number | 113601430 |
| Device Expiration Date | 2019-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | 1370 CREEKSIDE BOULEVARD NAPLES FL 341081945 US 341081945 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-10-18 |