PERSONA 2.5 MM FEMALE HEX SCREW 25 MM LENGTH

Description of Event or Problem

IT WAS REPORTED A PATIENT REPORTS PAIN, INTERMITTENT SWELLING, AND DEFORMITY SINCE SURGERY AND THEN BEGAN EXPERIENCING INSTABILITY, AND A FLEXION CONTRACTURE. RADIOGRAPHIC IMAGING DISPLAYED LUCENCY OF THE FEMORAL COMPONENT AND PATELLAR BUTTON AND 12 DEGREES VARUS ALIGNMENT OF THE TIBIAL COMPONENT. APPROXIMATELY ONE YEAR POST IMPLANTATION THE PATIENT UNDERWENT A REVISION FOR INSTABILITY, ARTHROFIBROSIS, AND MALALIGNMENT. ALL COMPONENTS, EXCEPT THE PATELLA, WERE REVISED WITHOUT COMPLICATION. DURING THE SURGERY, CULTURES WERE TAKEN AND LATER, ONE OF THE CULTURES FROM THE FEMORAL MEMBRANE, GREW EVIDENCE OF PROPIONIBACTERIUM ACNES. THE PATIENT WAS PLACED ON A THREE-MONTH COURSE OF ORAL DOXYCYCLINE. THE PATIENT HAS CONTINUED THROUGH THE STUDY WITHOUT ONGOING INFECTION RELATED COMPLICATIONS.

Additional Manufacturer Narrative

(B)(4). THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. ADDITIONAL ASSOCIATED PRODUCTS & MDRS 42530008302 PERSONA TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING RT SIZE H LOT# 64077392. MDR: 0001822565-2024-00496. 42502806602 PERSONA FEMUR TRABECULAR METAL CRUCIATE RETAINING (CR) STD POROUS LOT# 64317789. MDR: 0001822565-2024-00497.

Description of Event or Problem

NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B4, B5, G3, G6, H1, H2, H3, H6, H10, H11. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THE RADIOGRAPHS WERE NOT SUBMITTED AS THE FINDINGS/RESULTS WERE DOCUMENTED WITHIN THE MEDICAL RECORDS. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: PATIENT PRESENTED WITH PAIN, SWELLING, MILD EFFUSION, INSTABILITY AND LIMITED RANGE OF MOTION; RADIOLUCENCY UNDER FEMORAL POSTERIOR CONDYLES AND ANTERIOR FLANGE; TIBIAL MALALIGNMENT; INTRA-OP CULTURE POSITIVE FOR BACTERIAL MICROBIOLOGY. THIS COMPLAINT HAS BEEN CONFIRMED BY REVIEW OF THE PROVIDED MEDICAL RECORDS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO ACTIONS NEEDED AT THIS TIME. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.