MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-27 for PARAGON GM08001-354-00 manufactured by Global Orthopedic Technology (corin).
[186274366]
Tha with the paragon hip was performed on (b)(6) 2020. The calcar mill was used to perform this surgery. There was a size 8 broach in situ so the smaller mill was used. During the milling process, the surgeon fractured the femur and used a cable to prevent the fracture from propagating.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226188-2020-01507 |
| MDR Report Key | 9889155 |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-02-04 |
| Report Date | 2020-02-28 |
| Date Reported to Mfgr | 2020-02-28 |
| Date Added to Maude | 2020-03-27 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PARAGON |
| Generic Name | PROSTHESIS, HIP, SEMI-CONSTRAINED |
| Product Code | LZO |
| Date Received | 2020-03-27 |
| Catalog Number | GM08001-354-00 |
| Lot Number | J15-225 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GLOBAL ORTHOPEDIC TECHNOLOGY (CORIN) |
| Manufacturer Address | 17 BRIDGE STREET PYMBLE, AS NSW 2073 AS NSW 2073 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-27 |