FDA Adverse Event
Injury
Summary report: N
ENDURON NEUT 52OD X 28ID
MDR report key: 2060634
·
Received April 6, 2011
Report
- Report Number
- 1818910-2011-04821
- Event Type
- Injury
- Date Received
- April 6, 2011
- Report Date
- March 7, 2011
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- KWY
- PMA / PMN Number
- K940743
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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
IN (B)(6) 2010, MEDIAL DISLOCATION OF FEMUR OCCURRED. WHEN MANUAL REDUCTION WAS PERFORMED TO TREAT THE DISLOCATION, DISLOCATION OF THE HEAD OUT OF NECK OCCURRED. ON (B)(6) 2010, RE-SURGERY WAS DONE AND THE HEAD AND LINER WERE REPLACED. DURING SURGERY, IT WAS NOTED THAT THE STEM NECK WAS DARKENED. THE STEM WAS NOT REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDURON NEUT 52OD X 28ID | 87KWY; 87LZN; 87HRY; 87KWI; 87JDB | KWY | DEPUY ORTHOPAEDICS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Female | Required Intervention |