FDA Adverse Event
Injury
Summary report: N
PINN SECTOR W/GRIPTION 52MM
MDR report key: 2002838
·
Received February 16, 2011
Report
- Report Number
- 1818910-2011-02209
- Event Type
- Injury
- Date Received
- February 16, 2011
- Date of Event
- January 17, 2011
- Report Date
- January 17, 2011
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- LPH
- PMA / PMN Number
- K093646
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Description of Event or Problem · 1
PATIENT WAS REVISED BECAUSE CUP WAS NOT IN CORRECT VERSION AND THE PATIENT WAS DISLOCATING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PINN SECTOR W/GRIPTION 52MM | 87LPH; 87KWA; 87 JDI; 87LZO | LPH | DEPUY ORTHOPAEDICS, INC. | NA | E27L81000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |