FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER

Additional Manufacturer Narrative

(B)(4). PROPOSED COMPONENT CODE: MECHANICAL (G04) - HEAD. D10: CAT# 00875704801 LOT# 63134542 48MM O.D. SIZE GG POROUS UNCEMENTED WITH CLUSTER HOLES SHELL USE WITH GG LINERS. CAT# 00771101110 LOT# 63069429 FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS SIZE 11 STANDARD OFFSET REDUCED NECK LENGTH. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THROUGH A CLINICAL STUDY THAT THE PATIENT SUSTAINED A DISLOCATION APPROXIMATELY 9 YEARS AND 10 MONTHS POST-IMPLANTATION FOLLOWING A LEFT TOTAL HIP ARTHROPLASTY, WHICH WAS MANAGED WITH A SUCCESSFUL CLOSED REDUCTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.