MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-23 for HEMICAP PATELLO-FEMORAL WAVE KAHUNA ARTHROPLASTY SYSTEM PX75-0173/ PWL2-0855 manufactured by Arthrosurface, Inc..
| Report Number | 3004154314-2019-00007 |
| MDR Report Key | 8819933 |
| Date Received | 2019-07-23 |
| Date of Report | 2019-06-26 |
| Date Mfgr Received | 2019-06-26 |
| Date Added to Maude | 2019-07-23 |
| 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 | MR. PHANI PUPPALA |
| Manufacturer Street | 28 FORGE PARKWAY |
| Manufacturer City | FRANKLIN, MA 02038 |
| Manufacturer Country | US |
| Manufacturer Postal | 02038 |
| Manufacturer Phone | 5085203003 |
| Manufacturer G1 | PRIMO MEDICAL GROUP |
| Manufacturer Street | 75 MILL ST |
| Manufacturer City | STOUGHTON, MA 02072 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02072 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HEMICAP PATELLO-FEMORAL WAVE KAHUNA ARTHROPLASTY SYSTEM |
| Generic Name | PATELLO FEMORAL HEMIARTHROPLASTY SYSTEM |
| Product Code | KRR |
| Date Received | 2019-07-23 |
| Returned To Mfg | 2019-07-19 |
| Catalog Number | PX75-0173/ PWL2-0855 |
| Lot Number | 75DI1809/ 75BH0303 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHROSURFACE, INC. |
| Manufacturer Address | 28 FORGE PARKWAY FRANKLIN, MA 02038 US 02038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-07-23 |