FDA Adverse Event
Injury
Summary report: N
CONSERVE(R) TOTAL A-CLASS HEAD
MDR report key: 4093484
·
Received September 16, 2014
Report
- Report Number
- 3010536692-2014-01365
- Event Type
- Injury
- Date Received
- September 16, 2014
- Date of Event
- November 11, 2013
- Report Date
- August 20, 2014
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- JDL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- 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 EVENT IS STILL BEING INVESTIGATED AND IS NOT CLOSED. ADDITIONAL INFORMATION AND FINAL CONCLUSIONS WILL BE SUBMITTED UPON INVESTIGATION COMPLETION. TRENDS WILL BE EVALUATED.
Description of Event or Problem · 1
ALLEGEDLY THE PATIENT WAS REVISED DUE TO MOM COMPLICATIONS (LEFT).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 571110 | CONSERVE(R) TOTAL A-CLASS HEAD | HIP COMPONENT | JDL | MICROPORT ORTHOPEDICS INC. | 067442283 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Required Intervention |