FDA Adverse Event
Injury
Summary report: N
ROTAGLIDE+
MDR report key: 5056869
·
Received September 2, 2015
Report
- Report Number
- 9614209-2015-00050
- Event Type
- Injury
- Date Received
- September 2, 2015
- Date of Event
- August 11, 2015
- Report Date
- September 2, 2015
- Manufacturer
- CORIN LTD.
- Product Code
- JWH
- PMA / PMN Number
- K000232
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 0
(B)(4) INITIAL REPORT. DEVICE DETAILS, PATIENT MEDICAL HISTORY, POST PRIMARY AND PRE-REVISION X-RAYS HAVE BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION. DEVICE MANUFACTURING RECORDS WILL BE RETRIEVED AND REVIEWED ONCE APPROPRIATE DEVICE INFORMATION HAS BEEN PROVIDED.
Description of Event or Problem · 0
REVISION OF A ROTAGLIDE AND TIBIAL INSERT AFTER (B)(6), DUE TO PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 582832 | ROTAGLIDE+ | MODULAR TOTAL KNEE SYSTEM | JWH | CORIN LTD. | 102.312 | DATA NOT PROVIDED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 0 | Hospitalization | ROTAGLIDE+ TIBIAL BASEPLATE 102.101 |