VERSACEM ACETABULAR SHELL AND DOUBLE MOBILITY HC LINERS

Description of Event or Problem

THE PATIENT HAD PAIN DUE TO A DISLOCATION OF THE LINER DM FROM THE CONVERTER LINER AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA. THE PATIENT HAS PREVIOUSLY HAD SPINAL SURGERY WHICH HAS LIMITED THEIR MOBILITY. THE SURGEON OBSERVED THAT THE HIP CONSTRUCT WOULD BE PROVIDE MORE MOBILITY AND STABILITY IF IT WAS REVISED. THE PATIENT HAS PREVIOUSLY HAD SPINAL SURGERY, WHICH HAS LIMITED THEIR MOBILITY. AT ABOUT 20 DAYS FROM PRIMARY THE SURGEON REVISED THE AMISTEM-P STD. SIZE 1 TO AN AMISTEM-P LAT. SIZE 1, REVISED THE DOUBLE MOBILITY HC LINER D 28/DMC TO A FACE CHANGE 10° PE HC LINER D 40/F, REVISED THE 28MM BIOLOX DELTA HEAD S TO A 40MM BIOLOX DELTA HEAD S, AND REVISED THE ACETABULAR SHELL D 52 TWO-HOLES TO AN ACETABULAR SHELL D 54 TWO-HOLES T. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE CERAMIC HEAD WAS STILL COUPLED IN THE DOUBLE MOBILITY LINER AND THIS CONSTRUCT DISLOCATED FROM THE DM CONVERTER LINER.

Additional Manufacturer Narrative

BATCH REVIEWS PERFORMED ON 15 JUNE 2026: LINER: MPACT DM 01.26.2846MHC DOUBLE MOBILITY HC LINER D 28/DMC (K241767) LOT: 2338169: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-DEC-2023. EXPIRATION DATE: 22-NOV-2028. 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 DM 01.32.3844CF DM CONVERTER E/DMC - TIN COATED (K211891) LOT: 2309715: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-NOV-2023. EXPIRATION DATE: 23-OCT-2028. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE 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 REPORTED EVENT CONSISTED OF DISLOCATION OF THE DOUBLE MOBILITY CONSTRUCT, WITH THE CERAMIC HEAD STILL COUPLED IN THE DOUBLE MOBILITY LINER, FROM THE DM CONVERTER LINER. NO TRAUMA WAS INDICATED; HOWEVER, CASE-SPECIFIC CLINICAL FACTORS, INCLUDING THE PATIENT¿S PREVIOUS SPINAL SURGERY AND LIMITED MOBILITY, MAY HAVE CONTRIBUTED TO REDUCED STABILITY AND THE NEED FOR REVISION. THE DEVICE HISTORY RECORD REVIEWS FOR THE INVOLVED LINER AND DM CONVERTER LINER LOTS DID NOT INDICATE ANY POTENTIALLY RELATED MANUFACTURING ISSUE, AND NO SIMILAR EVENTS WERE IDENTIFIED FOR THE REVIEWED SOLD ITEMS OF THE SAME LOTS.