COCR FEMORAL BALL HEAD

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 10 JUL 2026 BALL HEADS: COCR 01.25.012 COCR BALL HEAD 12/14 D 28 MM SIZE M (K072857) LOT 123620: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23/OCT/2012. EXPIRATION DATE: 31/AUG/2017. 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: VERSACEM 01.26.2856MHC DOUBLE MOBILITY HC LINER D 28/DMH (K092265) LOT 130736: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21/MAR/2013. EXPIRATION DATE: 28/FEB/2018. 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: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

Description of Event or Problem

AT 12 YEARS 6 MONTHS FROM PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE COCR 28MM HEAD TO A 28MM BIOLOX DELTA HEAD L, AND REVISED THE DOUBLE MOBILITY HC LINER 56/28 TO A DOUBLE MOBILITY HC LINER D 28/DMH. THE SURGERY WAS COMPLETED SUCCESSFULLY.