FDA Adverse Event
Injury
Summary report: N
PROFEMUR(R) R PROXIMAL BODY
MDR report key: 3971684
·
Received July 31, 2014
Report
- Report Number
- 3010536692-2014-01050
- Event Type
- Injury
- Date Received
- July 31, 2014
- Report Date
- July 2, 2014
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- LZO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINT DATABASE WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT.
Additional Manufacturer Narrative · 1
THIS IS THE SAME EVENT AS 3010536692-2014-01051, -01052. THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
ALLEGEDLY PER PRESENTATION BY (B)(6) IN (B)(6) 2014, 1 HIP WAS REVISED FOR A DEEP INFECTION. NO FURTHER DETAILS OF THE REVISION OR THE PATIENTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 447813 | PROFEMUR(R) R PROXIMAL BODY | HIP COMPONENT | LZO | MICROPORT ORTHOPEDICS INC. | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |