FDA Adverse Event
Injury
Summary report: N
TC-PLUS
MDR report key: 1520613
·
Received November 2, 2009
Report
- Report Number
- 9613369-2009-00159
- Event Type
- Injury
- Date Received
- November 2, 2009
- Report Date
- November 2, 2009
- Manufacturer
- AARAU SWITZERLAND MANUFACTURING SITE
- Product Code
- KRP
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NA
Description of Event or Problem · 1
IT HAS BEEN REPORTED BY ANOTHER COUNTRY'S FACILITY TO SMITH & NEPHEW THAT A REVISION SURGERY WAS PERFORMED DUE TO INSTABILITY. THE REVISION OCCURRED APPROXIMATELY 1-3 YEARS AFTER IMPLANTATION. THIS IS ALL OF THE INFO THAT HAS BEEN RECEIVED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TC-PLUS | FEMORAL/TIBIAL / KRP | KRP | AARAU SWITZERLAND MANUFACTURING SITE | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Hospitalization| R |