RINGLOC SCREWIN PROV +3/HW 36 SZ23
Received Jun 19, 2012 · Event occurred May 22, 2012
Report 0001825034-2012-00883 · MDR key 2621239
Device
Generic name
Template
Manufacturer
Biomet OrthopedicsModel number
N/ACatalog number
31-108323
Lot number
053360
Product problems
- Difficult to Remove
- Device Slipped
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2012. DURING THE PROCEDURE, AS THE ACETABULAR CUP WAS IMPACTED, THE LOCKING RING CAME OUT. AFTER TRIALING, THE TRIAL LINER WAS DIFFICULT TO REMOVE. SUBSEQUENTLY, THE SURGEON INSTALLED A NEW LOCKING RING IN THE ACETABULAR CUP, BUT HAD DIFFICULTIES LOCKING THE ACETABULAR LINER IN PLACE. THE SURGEON USED A DIFFERENT ACETABULAR CUP, LINER, MODULAR HEAD, AND TAPERLOC STEM TO COMPLETE THE PROCEDURE. A DELAY OF MORE THAN HALF AN HOUR OCCURRED.
Additional Manufacturer Narrative
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.
Additional Manufacturer Narrative
VISUAL INSPECTION OF TRIAL SHOWS SIGNS OF DAMAGE ON THE SCALLOPS FROM THE ATTEMPTS AT REMOVAL. THERE ARE ADDITIONALLY TWO AREAS WITH MINOR DAMAGE/SCUFFING IN THE RING GROOVE THAT APPEAR NEAR THE SCALLOP DAMAGE, ALSO PRESUMABLY FROM REMOVAL. DIMENSIONS FOR THE LOCKING RING GROOVE MET SPECIFICATIONS. THE REPORTED EVENT COULD NOT BE SUBSTANTIATED.