FDA Adverse Event
Injury
Summary report: N
14/16 LG TAPER M HEAD 36MM+5
MDR report key: 3093986
·
Received May 6, 2013
Report
- Report Number
- 1818910-2013-16565
- Event Type
- Injury
- Date Received
- May 6, 2013
- Date of Event
- April 24, 2013
- Report Date
- January 28, 2015
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- JDI
- PMA / PMN Number
- K120599
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS CONSIDERED CLOSED.
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.
Additional Manufacturer Narrative · 1
DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.
Description of Event or Problem · 1
PATIENT WAS REVISED TO ADDRESS HIGH COCR LEVELS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 196787 | 14/16 LG TAPER M HEAD 36MM+5 | FEMORAL HEAD | JDI | DEPUY ORTHOPAEDICS INC US | 2934378 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |