E-POLY 36MM +3 HIWALL LNR SZ23

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: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 4 STATES, "LOOSENING, MIGRATION, OR FRACTURE OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, MALPOSITION, NON-UNION, BONE RESORPTION, AND/OR EXCESSIVE, UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY." NUMBER 8 STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION, MALALIGNMENT, MALPOSITION, EXCESSIVE, UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY, TRAUMA, WEIGHT GAIN, OR OBESITY." NUMBER 9 STATES, "FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, AND/OR EXCESSIVE WEIGHT." NUMBER 14 STATES, "POSTOPERATIVE BONE FRACTURE AND PAIN." (B)(4). THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2016-00870 / 00871 / 00900). REQUESTED BUT NOT RETURNED BY HOSPITAL

Description of Event or Problem

IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, PATIENT EXPERIENCED A SERIES OF "GIVING WAY" WHICH RESULTED IN FALLS. THE PATIENT REQUIRED CONVALESCENCE FROM A CERVICAL SPINE FRACTURE THAT PATIENT SUFFERED FROM ONE OF THE FALLS. THE PATIENT WAS REVISED ON (B)(6) 2016 DUE TO RECURRENT SUBLUXATION, IMPINGEMENT OF STEM ON SHELL CAUSING LINER FAILURE, PAIN, POSSIBLE LOOSENING, MISALIGNMENT OF THE FEMORAL HEAD, AND SEVERE ANTALGIC GAIT. OPERATIVE REPORT NOTED METALLIC STAINED CYSTIC STRUCTURES, COMPLETELY ABSENT POSTERIOR EXTERNAL ROTATORS AND POSTERIOR CAPSULE, METALLIC STAINING ON THE CERAMIC HEAD, WELL-FIXED FEMORAL STEM, FRACTURED LINER, BENT AND FRACTURED LOCKING RING, AND EROSION OF THE ACETABULAR COMPONENT DURING THE PROCEDURE. THE CERAMIC HEAD, LINER, CUP, AND SCREWS WERE REMOVED AND REPLACED.