FDA Adverse Event
Malfunction
Summary report: N
RINGLOC BI-POLAR CUP
MDR report key: 1181539
·
Received October 2, 2008
Report
- Report Number
- 1825034-2008-00247
- Event Type
- Malfunction
- Date Received
- October 2, 2008
- Date of Event
- August 20, 2008
- Report Date
- September 3, 2008
- Manufacturer
- BIOMET INC.
- Product Code
- JDI
- PMA / PMN Number
- K051569
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A FAX WAS SENT TO INFORM THE USER FACILITY OF THE EVENT. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO FDA. THE FOLLOWING USER FACILITY INFORMATION IS AVAILABLE: THIS REPORT FILED OCTOBER 2, 2008
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL BI-POLAR ARTHROPLASTY IN 2008. DURING THE PROCEDURE, THE POLYETHYLENE LINER DID NOT LOCK INTO THE ACETABULAR SHELL PROPERLY. PRODCEDURE WAS COMPLETED UTILIZING A UNI-POLAR PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RINGLOC BI-POLAR CUP | PROSTHESIS, HIP COMPONENT | JDI | BIOMET INC. | N/A | 681310 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |