MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-30 for CORIN OPTIMIZED POSITIONING SYSTEM 1248-0500 manufactured by Optimized Ortho Pty Ltd.
[186847498]
We are currently in the process of obtaining further information and complete the root cause investigation. The final report will be sent upon closure of root cause investigation. This report is filed with the fda due to an event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.
Patient Sequence No: 1, Text Type: N, H10
[186847499]
Patient underwent primary procedure for tha in (b)(6) 2018. Patient has recently complained of significant pain. Therefore, patient underwent revision procedure on (b)(6) 2020. During primary procedure , ops technology (ops plan with dha & acetabular guide and femoral guide) were employed as assistive technology.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012916784-2020-00056 |
| MDR Report Key | 9901928 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-30 |
| 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 SIMRAT GILL |
| Manufacturer Street | 17 BRIDGE STREET |
| Manufacturer City | PYMBLE, NSW 2073 |
| Manufacturer Country | AS |
| Manufacturer Postal | 2073 |
| Manufacturer G1 | OPTIMIZED ORTHO PTY LTD |
| Manufacturer Street | 17 BRIDGE STREET |
| Manufacturer City | PYMBLE, NSW 2073 |
| Manufacturer Country | AS |
| Manufacturer Postal Code | 2073 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CORIN OPTIMIZED POSITIONING SYSTEM |
| Generic Name | HIP PROSTHESIS |
| Product Code | LZO |
| Date Received | 2020-03-30 |
| Model Number | 1248-0500 |
| Lot Number | RUS_MB_10625 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OPTIMIZED ORTHO PTY LTD |
| Manufacturer Address | 17 BRIDGE STREET PYMBLE, NSW 2073 AS 2073 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-30 |