FDA Adverse Event
Injury
Summary report: N
ELITE PLUS SZ 2 FLANGED
MDR report key: 2002806
·
Received February 17, 2011
Report
- Report Number
- 1818910-2011-00923
- Event Type
- Injury
- Date Received
- February 17, 2011
- Date of Event
- December 6, 2010
- Report Date
- January 18, 2011
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- JDI
- PMA / PMN Number
- K871867
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
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.
Additional Manufacturer Narrative · 1
THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED FOR EXAMINATION. THE REFERENCED LOT CODE INVOLVED IN THE CURRENT COMPLAINT IS PART OF THE BATCHES CONCERNED BY A RECALL. THIS RECALL WAS PERFORMED BECAUSE THE CONCERNING PARTS WERE LASER ETCHED ON THE NECK AND SUBSEQUENTLY THERE WERE A RISK OF FRACTURE OF THE STEM. NO CORRECTIVE ACTION REQUIRED. CORRECTIVE ACTION IMPLEMENTED IN 2003-2004. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.
Description of Event or Problem · 1
REVISION DUE TO LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ELITE PLUS SZ 2 FLANGED | 87JCX | JDI | DEPUY ORTHOPAEDICS, INC. | NA | 00JWW09 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |