MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-24 for STEM: AMISTEM H HA COATED STD STEM SIZE 3 01.18.133 manufactured by Medacta International Sa.
| Report Number | 3005180920-2020-00188 |
| MDR Report Key | 9872424 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-02-25 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2014-03-07 |
| Date Added to Maude | 2020-03-24 |
| 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. STEFANO BAJ |
| Manufacturer Street | STRADA REGINA |
| Manufacturer City | CASTEL SAN PIETRO, SWITZERLAND 6874CHE |
| Manufacturer Country | SZ |
| Manufacturer Postal | 6874 CHE |
| Manufacturer G1 | MEDACTA INTERNATIONAL SA |
| Manufacturer Street | STRADA REGINA CASTEL SAN PIETRO 6874, SZ |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STEM: AMISTEM H HA COATED STD STEM SIZE 3 |
| Generic Name | HIP CEMENTLESS STEM |
| Product Code | LZO |
| Date Received | 2020-03-24 |
| Model Number | 01.18.133 |
| Catalog Number | 01.18.133 |
| Lot Number | 136187 |
| Device Expiration Date | 2019-01-31 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDACTA INTERNATIONAL SA |
| Manufacturer Address | STRADA REGINA CASTEL SAN PIETRO, 6874,CHE SZ 6874, CHE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-24 |