FDA Adverse Event
Injury
Summary report: N
CMK STEM
MDR report key: 1961940
·
Received January 15, 2011
Report
- Report Number
- 8010764-2011-00002
- Event Type
- Injury
- Date Received
- January 15, 2011
- Date of Event
- June 3, 2010
- Report Date
- January 15, 2010
- Manufacturer
- SMITH & NEPHEW ORTHOPAEDICS, INC. GERMANY
- Product Code
- JDH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REVISION SURGERY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CMK STEM | CMK21 STEM, 12/14 TAPER 4S1 | JDH | SMITH & NEPHEW ORTHOPAEDICS, INC. GERMANY | 76539426 | 09MT37667 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |