BIOLOX PROSTHESIS HEAD 12/14 32MM L

Additional Manufacturer Narrative

MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

AN ADVERSE EVENT WAS REPORTED INVOLVING THE MEDICAL DEVICE NK562 - BIOLOX PROSTHESIS HEAD 12/14 32 MM L. SPECIFICALLY, IT WAS REPORTED THAT FOLLOWING HIP SURGERY IN 2017, THE PATIENT EXPERIENCED A FALL. SUBSEQUENT EVALUATION REPORTEDLY IDENTIFIED A FRACTURE OF THE IMPLANTED MEDICAL DEVICE. REVISION SURGERY IS REQUIRED. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - ADVERSE EVENT (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON THE PATIENT HARM, REVISION SURGERY. ADDITIONAL INFORMATION WAS NOT PROVIDED BUT HAS BEEN REQUESTED. THE ADVERSE EVENT IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4). INVOLVED COMPONENTS: NH054T - PLASMACUP SC SIZE 54 MM (AESCULAP AG REF. NO. (B)(4)); NK115T - BICONTACT H PLASMAPORE 12/14 SIZE 15 MM (AESCULAP AG REF. NO. (B)(4)); NH413 - SC/MSC PE-INSERT 32 MM 52/54 POST.WALL (AESCULAP AG REF. NO. (B)(4)).