FDA Adverse Event
Injury
Summary report: N
DURALOC APEX HOLE ELIMINATOR
MDR report key: 1220342
·
Received November 3, 2008
Report
- Report Number
- 1818910-2008-05015
- Event Type
- Injury
- Date Received
- November 3, 2008
- Report Date
- October 15, 2008
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- JDL
- PMA / PMN Number
- K920395
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION WAS NOT POSSIBLE, AS THE DEVICE REMAINS IMPLANTED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT CODE SINCE ITS RELEASE FOR DISTRIBUTION. BASED ON THE FEBRUARY 2004 RELEASE DATE OF THE PROVIDED PRODUCT/LOT IT IS POSSIBLE THE ROOT CAUSE IS RELATED TO DESIGN. A DESIGN IMPROVEMENT WAS ESTABLISHED IN 1996, TO ALLEVIATE MIGRATION OF THE DEVICE THROUGH THE ACETABULAR CUP. FURTHER CORRECTIVE ACTION IS NOT INDICATED AT THIS TIME.
Description of Event or Problem · 1
X-RAYS HAVE SHOWN THE HOLE ELIMINATOR WENT THROUGH THE CUP INTO THE BODY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURALOC APEX HOLE ELIMINATOR | 87JDL | JDL | DEPUY ORTHOPAEDICS, INC. | N/A | 931830000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Required Intervention |