TINBN COATED VANGUARD INTERLOK PS ANATOMIC FEMORAL COMPONENT 65MM LEFT

Additional Manufacturer Narrative

(B)(4). CONCOMITANT MEDICAL PRODUCTS: E1 VNGD PS+ TIB BRG 71/75X10, ITEM#: EP-183740, LOT#: 127810; SERIES A PAT STD 37 3 PEG, ITEM#: 184768, LOT#: 689980; BIOMET BONE CMENT R 1X40 JP, ITEM#: 110035372, LOT#: Z07BAC0902; TNBN POL COCR FIN TIB TRAY 71, ITEM# :141253TNBN, LOT#: 2020091428. REPORT SOURCE: FOREIGN: JAPAN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT PATIENT HAS ALLERGIC REACTION POSTOPERATIVELY, IN UNKNOWN TIMEFRAME AFTER KNEE SURGERY. METALLIC ALLERGY REACTION IS SUSPECTED. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

Additional Manufacturer Narrative

(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D2, D9, G1, G3, G6, H1, H2, H3, H6, H10. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. DEVICE IS USED FOR TREATMENT. MEDICAL RECORDS WERE NOT PROVIDED. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. H3 OTHER TEXT : DEVICE REMAINS IMPLANTED.

Description of Event or Problem

IT WAS REPORTED THAT PATIENT HAS ALLERGIC REACTION POSTOPERATIVELY, ABOUT TWO (2) MONTHS AFTER KNEE SURGERY. THE PATIENT IS ALLERGIC TO NICKEL. NO MEDICATIONS THAT MAY HAVE CAUSED THE REACTION CONFIRMED.