FDA Adverse Event
Injury
Summary report: N
UNKNOWN PTN NAIL
MDR report key: 2991107
·
Received March 6, 2013
Report
- Report Number
- 0001825034-2013-00469
- Event Type
- Injury
- Date Received
- March 6, 2013
- Date of Event
- February 11, 2013
- Report Date
- February 8, 2013
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- HSB
- PMA / PMN Number
- PK050118
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. PRODUCT IDENTIFICATION AND EXPIRY DATE, DATE IMPLANTED - UNKNOWN, MANUFACTURE DATE - UNKNOWN.
Description of Event or Problem · 1
IT WAS REPORTED PATIENT UNDERWENT A PERITROCHANTERIC NAIL PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY PATIENT'S FEMUR FRACTURED AND A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 TO IMPLANT A REVISION STEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 95817 | UNKNOWN PTN NAIL | ROD, FIXATION | HSB | BIOMET ORTHOPEDICS | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |