METHA ¿CAP 12/14 130°/0° SIZE 2

Additional Manufacturer Narrative

INVESTIGATION: DUE TO THE CIRCUMSTANCE THAT WE DID NOT RECEIVED ANY EXPLANTS, AN INVESTIGATION AT THE SAMPLE IS NOT POSSIBLE. THIS CASE WAS DISCUSSED WITH A SPECIALIST FROM THE MARKETING DEPARTMENT. THE X-RAY SHOWS BILATERAL METHA THA IN A MALE PATIENT. EXACT DATE OF INDEX SURGERIES (BOTH HIPS) IS NOT CONFIRMED. AS THE X-RAY IS FROM 2014 AND THE CURRENT CASE INFORMATION FROM 2017 WE ASSUME A CURRENT TIME IN VIVO OF ABOUT 4 YEARS. BATCH HISTORY REVIEW: A REVIEW OF THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS WAS NOT POSSIBLE BECAUSE THE LOT NUMBER IS UNKNOWN. CONCLUSION AND ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE THE ROOT CAUSE OF THE FAILURE IS PROBABLY NOT PRODUCT RELATED. RATIONAL: BOTH HIP STEMS SHOW EVIDENT RADIOLOGICAL SIGNS OF STEM LOOSENING WITH A CLEAR RADIOLUCENT LINE FORMATION AT GRUEN ZONE 1 PROXIMAL-LATERAL. RIGHT HIP STEM HAS A LATERAL-DISTAL PEDESTAL BONE FORMATION WHICH MAY BE INTERPRETED AS A SECONDARY RADIOLOGICAL SIGN OF IMPLANT LOOSENING. THEREFORE BOTH HIP STEMS MAY BE LOOSE AND SHOULD THEREFORE SHOW CLEAR CLINICAL SYMPTOMS OF PAIN IN BOTH HIP JOINT DURING LOAD AND WALKING. CUP IMPLANTS ALSO SHOW CERTAIN BUT UNCLEAR RADIOLOGICAL SIGNS OF BONE INTERFACE CHANGES IN CHARNLEY ZONES II AT THE BOTTOM OF THE PRESSFIT SHELL. BASED ON THE X-RAY INFORMATION FROM 2014 WE ASSUME AN EVOLUTION OF EARLY BILATERAL STEM LOOSENING. BASED ON AVAILABLE CLINICAL STUDIES OF THE METHA HIP STEM THIS IS A RARE SITUATION AND MAY HAPPEN WITHIN THE FIRST POSTOPERATIVE YEAR. A POSSIBLE ROOT CAUSE FOR THIS FAILURE COULD BE AN EXCESSIVE LOAD TO THE HIP PROSTHESIS SHORTLY AFTER IMPLANTATION. CORRECTIVE ACTION: ACCORDING TO SOP SA-DE13-M-4-2-01-010 A CAPA IS NOT NECESSARY.

Additional Manufacturer Narrative

(B)(4). MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING. DEVICE NOT RETURNED.

Description of Event or Problem

COUNTRY OF COMPLAINT: (B)(6). IT WAS REPORTED THAT ABOUT 5 YEARS LATER, THE PATIENT HAS A PROBLEM WITH OSTEOLYSIS SO THERE IS LOOSENING ON BOTH SIDES OF THE KNEE. NO REVISION SURGERY HAS BEEN SCHEDULED. ALL MED WATCH SUBMISSIONS RELATED TO THIS REPORT ARE: 9610612-2017-00293; 9610612-2017-00294.