MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-02-05 for STRYKER SCORPIO NRG * manufactured by Stryker.
[3286654]
Pt had stryker scorpio nrg total knee in five years ago at a hospital in unknown state to this reporter. Recently pt complaints of instablity, giving way, and pain. X-ray showed that the implants appeared to be stable. Discussed treatment options, which included revision arthroplasty to include either a polyethylene exchange versus complete revision. Since the initial surgery was done at another hospital, there is no identifying data except the stryker scorpio nrg size 5. Polyethylene. What was the original intended procedure? Either polyethylene exchange versus complete revision of all components. On (b)(6) 2012 went to surgery and had revision of right total knee arthroplasty, polyethylene exchange.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2948708 |
| MDR Report Key | 2948708 |
| Date Received | 2013-02-05 |
| Date of Report | 2013-02-04 |
| Date of Event | 2012-11-13 |
| Report Date | 2013-02-04 |
| Date Reported to FDA | 2013-02-05 |
| Date Reported to Mfgr | 2013-02-07 |
| Date Added to Maude | 2013-02-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRYKER SCORPIO NRG |
| Generic Name | PROSTHESIS,KNEE, POLYETHYLENE |
| Product Code | KMB |
| Date Received | 2013-02-05 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Age | 5 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER |
| Manufacturer Address | 325 CORPORATE DRIVE MAHWAH NJ 07430 US 07430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-05 |