MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S3 RM

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 24-MAR-2023: LOT 2212250: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-SEP-2022. EXPIRATION DATE: 2027-08-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIR DIRECTOR: SHORTLY AFTER PRIMARY UKA, THE PATIENT'S TIBIAL BONE GAVE WAY AND TRANSITION TO A TKR WAS REQUIRED. THE SURGEON COMMENTED THAT THIS PATIENT HAD VERY SOFT BONE; WE UNDERSTAND THAT THE SURGEON PROBABLY OFFERED TO THE PATIENT THE OPTION OF TRYING THE LESS INVASIVE PARTIAL REPLACEMENT BUT THE OUTCOME PROVED IMMEDIATELY NOT GOOD ENOUGH. THERE IS NO REASON TO SUSPECT A FAULTY DEVICE AT THE ORIGIN OF THIS FAILURE. INVESTIGATION PERFORMED BY MEDACTA KNEE R&D MANAGER: REVISION SURGERY OF A MOTO MEDIAL IMPLANT AFTER ONE MONTH FROM PRIMARY MOST LIKELY FOR SINKING OF THE TIBIAL COMPONENT. FROM THE PICTURES OF THE EXPLANTED IMPLANTS, RESIDUAL CEMENT AND BONE CAN BE SEEN ON THE TIBIAL AND FEMORAL COMPONENTS. NO ANOMALIES CAN BE IDENTIFIED ON THE IMPLANTS. AS COMMENTED BY THE SURGEON, THE PATIENT HAD A VERY SOFT BONE AND THIS WAS PROBABLY THE CAUSE FOR THE EVENT. FROM PRELIMINARY INVESTIGATION, BASED ON THE PICTURES OF THE REMOVED COMPONENTS AND THE EVENT DESCRIPTION, THERE ARE NO ELEMENTS TO SUSPECT THAT THE EVENT WAS RELATED TO A FAULTY DEVICE.

Description of Event or Problem

REVISION SURGERY PERFORMED AT ABOUT 1 MONTH AFTER THE PRIMARY DUE TO TIBIAL TRAY SUBSIDENCE. MOTO COMPONENTS HAVE BEEN SUCCESSFULLY REVISED WITH A GMK-SPHERE FEMORAL COMPONENT AND WITH GMK-REVISION TIBIAL COMPONENT, MEDIAL AUGMENTATION AND STEM. THE PATIENT HAS A VERY SOFT BONE.

Additional Manufacturer Narrative

REVISION SURGERY PERFORMED AT ABOUT 1 MONTH AFTER THE PRIMARY DUE TO TIBIAL TRAY SUBSIDENCE. MOTO COMPONENTS HAVE BEEN SUCCESSFULLY REVISED WITH A GMK-SPHERE FEMORAL COMPONENT AND WITH GMK-REVISION TIBIAL COMPONENT, MEDIAL AUGMENTATION AND STEM. THE PATIENT HAS A VERY SOFT BONE. THE BRANCH REPORTED TO US THAT THE SURGEON CONCLUDED IT WAS A SURGICAL FAILURE: THE SINTERING WAS CAUSED BY A SAGITAL RESECTION THAT WAS TOO DEEP.