FDA Adverse Event
Injury
Summary report: N
ARTICULEZE M HEAD 36MM +1.5
MDR report key: 2011439
·
Received March 4, 2011
Report
- Report Number
- 1818910-2011-03721
- Event Type
- Injury
- Date Received
- March 4, 2011
- Date of Event
- February 3, 2011
- Report Date
- February 3, 2011
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- JDI
- PMA / PMN Number
- K980513
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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.
Description of Event or Problem · 1
PATIENT REVISED FOR MASS IN HIP REGION, DISCOVERED THAT THE PROXIMAL FEMUR OF BALL WAS BASICALLY DEAD BONE. SURGEON STATED THAT HE DID NOT KNOW IF THIS CAME FROM THE METAL ON METAL ARTICULATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARTICULEZE M HEAD 36MM +1.5 | 87 JDI, LPH | JDI | DEPUY ORTHOPAEDICS, INC. | NA | VS9BS1004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention | NA. |