MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-09-10 for UNICOMPARTMENT KNEE IMPLANT UNK manufactured by Unk.
[3715000]
Pt s/p right uni knee replacement in 2008 complaining of ongoing knee pain. H and p as well as operative report describes failed unicompartment knee arthroplasty with varus deformity; fractured/failed tibial tray or implant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3370250 |
| MDR Report Key | 3370250 |
| Date Received | 2013-09-10 |
| Date of Report | 2013-09-09 |
| Date of Event | 2013-08-28 |
| Date Facility Aware | 2013-08-30 |
| Report Date | 2013-09-09 |
| Date Reported to FDA | 2013-09-09 |
| Date Added to Maude | 2013-09-27 |
| 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 | UNICOMPARTMENT KNEE IMPLANT |
| Generic Name | UNICOMPARTMENT KNEE IMPLANT |
| Product Code | HSH |
| Date Received | 2013-09-10 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 5 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2013-09-10 |