BIPOLAR HEADS

Description of Event or Problem

REVISION SURGERY DUE TO DISLOCATION OF BIPOLAR HEAD FROM THE ACETABULUM AFTER 20 DAYS FROM PRIMARY SURGERY. THE SURGEON REVISED THE HEAD WITH A HEAD WITH AN OPTION SLEEVE, AND THE BIPOLAR HEAD WAS CONVERTED TO A ZIMMER DUAL MOBILITY.

Additional Manufacturer Narrative

CLINICAL EVALUATION A FEW WEEKS AFTER PRIMARY PARTIAL HIP ARTHROPLASTY, DISLOCATION OF THE BIPOLAR HEAD FROM ACETABULUM OCCURS. THE SURGEON DECIDED TO CONVERTY PARTIAL ARTHROPLASTY TO TOTAL, REPLACING THE FEMORAL HEAD AND THE BIPOLAR CUP. NO REASON TO SUSPECT A FAULTY DEVICE AS THE CAUSE OF THE DISLOCATION. BATCH REVIEW PERFORMED ON 24 JUN 2026 LOT 2401376: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-JUN-2024. EXPIRATION DATE: 2029-JUN-03. 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. THE CLINICAL EVALUATION DOES NOT INDICATE ANY REASON TO SUSPECT A FAULTY DEVICE AS THE CAUSE OF THE BIPOLAR HEAD DISLOCATION, WHICH OCCURRED A FEW WEEKS AFTER PRIMARY PARTIAL HIP ARTHROPLASTY.