FDA Adverse Event
Injury
Summary report: N
PROFEMUR(R) NECK
MDR report key: 1883605
·
Received October 26, 2010
Report
- Report Number
- 1043534-2010-00440
- Event Type
- Injury
- Date Received
- October 26, 2010
- Report Date
- July 25, 2011
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- LPH
- PMA / PMN Number
- K021346
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2010-00441.
Additional Manufacturer Narrative · 1
CONCLUSION: NO CONCLUSION CAN BE DRAWN. NO SPECIFIC PART OR LOT NUMBERS WERE PROVIDED FOR QUALITY REVIEW OR FURTHER INVESTIGATION. PRODUCT CONFORMANCE COULD NOT BE DETERMINED. USE OF DEVICE COULD NOT BE DETERMINED.
Description of Event or Problem · 1
ALLEGEDLY REVISED DUE TO UNKNOWN REASONS.
Description of Event or Problem · 1
ALLEGEDLY REVISED DUE TO UNKNOWN REASONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROFEMUR(R) NECK | HIP COMPONENT | LPH | WRIGHT MEDICAL TECHNOLOGY, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |