COCR FEMORAL BALL HEAD

Description of Event or Problem

THE PATIENT HAD PRIMARY SURGERY USING NON-MEDACTA PRODUCTS. ON (B)(6) 2026, THE PATIENT WAS REVISED TO ALL MEDACTA IMPLANTS. PRESENTLY, ON (B)(6) 2026, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION WITH DRAINAGE AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED ALL IMPLANTS (STEM, HEAD, LINER, AND CUP) TO NEW MEDACTA IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 10 JULY 2026 BALL HEADS: COCR 01.25.034 COCR BALL HEAD 12/14 D 36 MM SIZE XXL (K080885) LOT 2108062: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-SEP-2021. EXPIRATION DATE: 26-AUG-2026. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. LINER: MPACT 01.32.3648HCT FLAT PE HC LINER D 36/F (K103721) LOT 2532101: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-JAN-2026. EXPIRATION DATE: 07-JAN-2031. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. STEM: SMS SOLID 01.36.053 SMS SOLID STEM STD SIZE 13 (K181693) LOT 2341351: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-FEB-2024. EXPIRATION DATE: 06-FEB-2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CUP: MPACT 3D METAL 01.38.062MH MPACT 3D METAL SHELL MULTI HOLE D 62MM (K171966) LOT 2520304: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-NOV-2025. EXPIRATION DATE: 23-OCT-2030. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE 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.