FDA Adverse Event
Other
Summary report: N
UNIGLIDE UNICONDYLAR KNEE PROSTHESIS
MDR report key: 3593238
·
Received January 14, 2014
Report
- Report Number
- 9614209-2013-00136
- Event Type
- Other
- Date Received
- January 14, 2014
- Date of Event
- September 9, 2013
- Report Date
- November 13, 2013
- Manufacturer
- CORIN, LTD.
- Product Code
- HRY
- PMA / PMN Number
- K050764
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PT NOTES, MEDICAL HISTORY, DEVICE DETAILS, EXPLANT, X-RAYS TO BE REQUESTED, SO INCIDENT CAN BE INVESTIGATED. DEVICE HISTORY RECORDS TO BE REVIEWED.
Description of Event or Problem · 1
UNIGLIDE REVISION DUE TO PROGRESSION OF OA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 37672 | UNIGLIDE UNICONDYLAR KNEE PROSTHESIS | HRY UNICONDYLAR KNEE PROSTHESIS | HRY | CORIN, LTD. | 515.0300 | 160782 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention | ASSOCIATED TIBIAL COMPONENT: 530.1511, LOT| CODE 183944| ASSOCIATED INSERT COMPONENT: UNKNOWN |