MECTACER BIOLOX DELTA FEMORAL BALL HEAD

Description of Event or Problem

THE PATIENT CAME IN PRESENTING PAIN DUE TO HIP SUBLUXATION AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA OR A FALL.ABOUT 1 YEAR AND 7 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE MEDACTA CUP AND LINER TO A COMPETITOR CUP AND LINER AND REVISED THE 36MM BIOLOX DELTA HEAD M TO A 28MM BIOLOX OPTION HEAD WITH L OPTION SLEEVE.

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 16 JULY 2026 BALL HEADS: MECTACER 01.29.209 MECTACER HEAD BIOLOX DELTA DIA.36 12/14-M (K112115) LOT 2418027: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JUL-2024. EXPIRATION DATE: 23-JUN-2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. LINER: MPACT 01.32.3644HCT FLAT PE HC LINER D 36/E (K103721) LOT 2417827: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JUL-2024. EXPIRATION DATE: 26-JUN-2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE:BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.