InjuryIQO
RINGLOC MAXROM +TRIAL LINER SIZE 23 X 36MM I.D.
Received Jul 11, 2012
Report 0001825034-2012-01022 · MDR key 2651399
Device
Generic name
Template
Manufacturer
Biomet OrthopedicsModel number
N/ACatalog number
31-108223
Lot number
755820
Product problems
- Fracture
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A TOTAL HIP ARTHROPLASTY, THE CENTER SCREW FRACTURED OUT OF THE TRIAL LINER. IT IS POSSIBLE INTERVENTION WAS REQUIRED TO RETRIEVE FRACTURED PIECE FROM PATIENT.
Additional Manufacturer Narrative
CORRECTIVE AND PREVENTIVE ACTIONS ARE IN PROCESS. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION.