FDA Adverse Event
Injury
Summary report: N
CONTOUR RECONSTRUCTION RING
MDR report key: 6067063
·
Received October 31, 2016
Report
- Report Number
- 1020279-2016-00839
- Event Type
- Injury
- Date Received
- October 31, 2016
- Report Date
- October 3, 2016
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JDJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
WHILE PERFORMING A LITERATURE REVIEW (CROCKARELL JR, JR. INTERMEDIATE-TERM RESULTS WITH A MODIFIED ANTIPROTRUSIO CAGE IN ACETABULAR REVISION SURGERY. AM J ORTHOP (BELLE MEAD NJ). 2009;38(9):E144-148.)FOR THE CONTOUR ACETABULAR RINGS, THE FOLLOWING INCIDENT WAS FOUND: A DEVICE WAS REPORTED TO HAVE FRACTURED, RESULTING IN A REVISION OF THE HIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 718674 | CONTOUR RECONSTRUCTION RING | PROSTHESIS, HIP, ACETABULAR MESH | JDJ | SMITH & NEPHEW, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |