BIOMET OFFSET TIBIAL TRAY ADAPTOR 5.0 MM

Additional Manufacturer Narrative

UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THIS DEVICE SHOULD NOT HAVE BEEN REPORTED AS IT WAS NOT INVOLVED IN THE EVENT. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

Additional Manufacturer Narrative

MEDICAL PRODUCTS - VANGUARD(TM) FEMORAL DISTAL AUGMENT 10MM X 60MM LL/RM CATALOG# 184202 LOT# 769060, VANGUARD (TM) FEMORAL DISTAL AUGMENT 10MM X 60MM RL/LM CATALOG# 184182 LOT# 807910, BIOMET SPLINED KNEE STEM 14MM X 120 MM CATALOG# 141654 LOT# 485730, VANGUARD (TM) FEMORAL POSTERIOR AUGMENT 5MM X 60MM LL/RM CATALOG# 184162 LOT# 741160, BIOMET SPLINED KNEE STEM 10MM X 80MM CATALOG# 141610 LOT# 298100, VANGUARD (TM) FEMORAL POSTERIOR AUGMENT 5MM X 60 MM RL/LM CATALOG# 184142 LOT# 668770, BIOMET OFFSET TIBIAL TRAY 63MM CATALOG# 141481 LOT# 894190, BIOMET SERIES A THIN PATELLA 37MM X 8.6 MM CATALOG# 184788 LOT# 968230, VANGUARD (TM) DCM TIBIAL BEARING 20MM X 63/67 MM SMALL POST CATALOG# 183830 LOT# 073550, CUSTOM TITANIUM VANGUARD SSK FEMORAL CATALOG# CP113123 LOT# 474920. EVENT IS BEING REPORTED TO FDA ON ELEVEN MEDWATCHES SINCE THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE OCCURRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND, IF WARRANTED, FURTHER MEDWATCH REPORTS WILL BE SUBMITTED. THIS REPORT IS NUMBER 6 OF 11 MDRS FILED FOR THE SAME PATIENT (REFERENCE 0001825034 - 2017 - 00253, 0001825034 - 2017 - 00255, 0001825034 - 2017 - 00257, 0001825034 - 2017 - 00258, 0001825034 - 2017 - 00259, 0001825034 - 2017 - 00262, 0001825034 - 2017 - 00264, 0001825034 - 2017 - 00265, 0001825034 - 2017 - 00266, 0001825034 - 2017 - 00267).

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS SEVEN (7) MONTHS POST IMPLANTATION.