FDA Adverse Event
Injury
Summary report: N
TRINITY ACETABULAR SYSTEM
MDR report key: 2452509
·
Received February 10, 2012
Report
- Report Number
- 9614209-2012-00007
- Event Type
- Injury
- Date Received
- February 10, 2012
- Date of Event
- October 6, 2011
- Report Date
- January 11, 2012
- Manufacturer
- CORIN, LTD.
- Product Code
- MEH
- PMA / PMN Number
- K0093472
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CAPA COMPLAINT (B)(4).
Description of Event or Problem · 1
ACETABULAR SCREW WENT THROUGH CUP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRINITY ACETABULAR SYSTEM | MEH PROST HIP SEMI-CONST | MEH | CORIN, LTD. | 196985 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Hospitalization| R |