22.2MM DIA COCR MOD HD -3MM NK
Received Jul 30, 2015 · Event occurred Jul 8, 2015
Report 0001825034-2015-03447 · MDR key 4954487
Device
Generic name
Prosthesis, Hip
Manufacturer
Biomet OrthopedicsModel number
N/ACatalog number
163653
Lot number
990240
Product problems
- Detachment of Device or Device Component
- Device Dislodged or Dislocated
Patient
51 YR
- No Code Available
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL HIP ARTHROPLASTY ON (B)(6) 2015. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2015 DUE TO DISLOCATION. DURING THE REVISION, THE LOCKING RING POPPED OFF WHILE IMPACTING THE LINER INTO THE ACETABULAR CUP. ANOTHER LINER WAS UTILIZED TO COMPLETE THE PROCEDURE AND THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED.
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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2015-03447 & 03448).