MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-04 for FITMORE HIP STEM, TRIAL RASP, B/9 N/A 01.00559.209 manufactured by Zimmer Gmbh.
| Report Number | 0009613350-2019-00428 |
| MDR Report Key | 8761943 |
| Date Received | 2019-07-04 |
| Date of Report | 2019-08-05 |
| Date of Event | 2019-06-25 |
| Date Mfgr Received | 2019-07-08 |
| Device Manufacturer Date | 2015-10-19 |
| Date Added to Maude | 2019-07-04 |
| 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 | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER GMBH |
| Manufacturer Street | SULZER ALLEE 8 SULZER INDUSTRIE PARK |
| Manufacturer City | WINTERTHUR 8404 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 8404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FITMORE HIP STEM, TRIAL RASP, B/9 |
| Generic Name | N/A |
| Product Code | HTR |
| Date Received | 2019-07-04 |
| Model Number | N/A |
| Catalog Number | 01.00559.209 |
| Lot Number | 152826274 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER GMBH |
| Manufacturer Address | SULZER ALLEE 8 SULZER INDUSTRIE PARK WINTERTHUR 8404 SZ 8404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-07-04 |