FDA Adverse Event
Injury
Summary report: N
RINGLOC ACETABULAR LINER 28MM
MDR report key: 2122272
·
Received June 13, 2011
Report
- Report Number
- 1825034-2011-00504
- Event Type
- Injury
- Date Received
- June 13, 2011
- Date of Event
- May 17, 2011
- Report Date
- May 19, 2011
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- LPH
- PMA / PMN Number
- K926107
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. THE LOT NUMBER INFORMATION NEEDED TO REVIEW DEVICE HISTORY RECORDS WAS UNAVAILABLE. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS REPORT SUBMITTED (B)(4), 2011.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6), 1997. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6), 2011, DUE TO PAIN AND A CYST BEHIND THE ACETABULAR CUP. THE MODULAR HEAD AND ACETABULAR LINER WERE REMOVED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RINGLOC ACETABULAR LINER 28MM | PROSTHESIS, HIP | LPH | BIOMET ORTHOPEDICS | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |