MAUDE Adverse Event Report: EXACTECH, INC. TRAPEZOID TIBIAL TRAY SZ 5F/4T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	TRAPEZOID TIBIAL TRAY SZ 5F/4T
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: tibial augment block 1/3-sz 4 8mm (cat# 204-44-08 / serial# (b)(4)) logic stem ext 16mm x 160mm (cat# 02-012-60-1616 / serial# (b)(4)) cc tibial insert sz 5, 18mm (cat# 208-25-18 / serial# (b)(4)) as reported, this (b)(6) male patient returned to hss experiencing right knee pain 10 years after receiving a revision knee replacement.The tibia was the issue and the surgeon decided to revise only the tibial component if the femur was well fixed.Upon exposure it was determined that the femoral component was well fixed, and the surgeon decided to perform a tibial revision.The patient had a size 5 femur and tibial components both augmented.Due to minor bone loss upon further resection, he decided to go down on the tibia to a size 4 tray.The tibial augment went down from an 11mm to an 8mm staying with a 1/3 coverage.The knee was deemed stable using an 18mm cck insert.Having used a 120mm stem on the previous revision the surgeon decided to go with a 160mm stem for this revision.The device will not be returned for evaluation due to hospital retains all retrievals.Patient was last known to be in stable condition following the event.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design, manufacturing, or patient related issues.The cause of the pain and subsequent revision cannot be conclusively determined; however, it is most likely is related to the patients underlying condition.
Event or Problem Description
As reported, this (b)(6) male patient returned to hss experiencing right knee pain 10 years after receiving a revision knee replacement.The tibia was the issue and the surgeon decided to revise only the tibial component if the femur was well fixed.Upon exposure it was determined that the femoral component was well fixed, and the surgeon decided to perform a tibial revision.The patient had a size 5 femur and tibial components both augmented.Due to minor bone loss upon further resection, he decided to go down on the tibia to a size 4 tray.The tibial augment went down from an 11mm to an 8mm staying with a 1/3 coverage.The knee was deemed stable using an 18mm cck insert.Having used a 120mm stem on the previous revision the surgeon decided to go with a 160mm stem for this revision.The device will not be returned for evaluation due to hospital retains all retrievals.Patient was last known to be in stable condition following the event.

• Brand Name: TRAPEZOID TIBIAL TRAY SZ 5F/4T
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11611936
• Report Number: 1038671-2021-00152
• Device Sequence Number: 11534647
• Product Code: JWH
• UDI-Device Identifier: 10885862047717
• UDI-Public: 10885862047717
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/18/2014
• Device Model Number: TRAPEZOID TIBIAL TRAY SZ 5F/4T
• Device Catalogue Number: 204-04-54
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 04/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 71 YR
• Patient Weight: 101