PERSONA THE PERSONALIZED KNEE

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: B4; B5; D2; G1; G3; G6; H1; H2; H3; H6. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: MRI FOR LEFT KNEE PAIN IDENTIFIED A MARKED CYSTIC CHANGE THROUGHOUT THE PATELLA ALONG THE COURSE OF THE PROSTHESIS SCREWS. PHONE CALL WITH PATIENT STATED ONSET OF KNEE PAIN/POSTERIOR SWELLING/NUMBNESS/DIFFICULTY AMBULATING & LIMPING. PATIENT RESTARTED PHYSICAL THERAPY WHERE MULTIPLE CYSTS PRESENT. SUBSEQUENT MRI FOR CHRONIC L KNEE PAIN IDENTIFIED SUGGESTION OF LOBULATED CYSTIC FOCI DEEP TO THE PATELLAR COMPONENT MEASURING APPROXIMATELY 3CM THAT MAY BE RELATED TO DEGENERATIVE CHANGES BUT LOOSENING IS ALSO IN THE DIFFERENTIAL. MODERATE THICKENING OF QUAD AND PATELLAR TENDON ALSO IDENTIFIED, WHICH IS LIKELY POST-SURGICAL CHANGE/TENDINOPATHY-OTHER TENDONS UNREMARKABLE, LIGAMENTS GROSSLY INTACT, SMALL JOINT EFFUSION, NO APPRECIABLE POPLITEAL CYST, NO GROSS ACUTE FRACTURE, NO GROSS SUBLUXATIONS. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT CAN BE CONFIRMED BASED ON THE PROVIDED MEDICAL RECORDS. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Additional Manufacturer Narrative

(B)(4). D10: ITEM# 42509902525; LOT# 62151277, ITEM# 42512400810; LOT# 62322823, ITEM# 42540200032; LOT# 62407081, ITEM# 42532007101; LOT# 62401165, ITEM# 42500006801; LOT# 62115676, ITEM# 00111214001; LOT# 76384339, ITEM# 00111214001; LOT# 76384339. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT KNEE PROCEDURE APPROXIMATELY ELEVEN (11) YEARS AGO. SUBSEQUENTLY, THE PATIENT IS NOW EXPERIENCING PAIN AND LIMPING AND HAS TWO CYSTS IN THEIR KNEE CAP. PATIENT RESUMED PT APPROXIMATELY THREE (3) MONTHS AGO AND SAW SOME IMPROVEMENT. A RECOMMENDATION TO RECEIVE REVISION SURGERY HAS BEEN MADE, BUT NO SURGERY HAS BEEN SCHEDULED YET. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

Additional Manufacturer Narrative

D10: ITEM# 42509902525; LOT# 62151277. ITEM# UNK SZ 13 PS INSERT; LOT# UNKNOWN. ITEM# 42540200032; LOT# 62407081. ITEM# 42532007101; LOT# 62401165. ITEM# 42500006801; LOT# 62115676. ITEM# 00111214001; LOT# 76384339. ITEM# 00111214001; LOT# 76384339. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

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