MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 1, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC TIBIA IMPLANT PSC INSERT, SZ 1, 11MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 2.5 years post initial left tka, this (b)(6) y/o female patient had a revision due to chronic hydrarthrosis occurring after somewhat prolonged walks.Patient had pe issue and patient painful while walking.There was evidence of poly wear.Patient was slightly lax, surgeon explained to patient, until proven otherwise, that synovectomy is necessary with replacement of a slightly thicker insert (13 vs 11mm).The wear marks on the center cam foot were real but relatively unobtrusive.The synovial fluid was not very abundant and it was perfectly clear.Patient was revised to exactech devices.There was no breakage of device or surgical delay/prolongation reported.Photos and x-rays received, the device will be return.
Additional Manufacturer Narrative
As reported, approximately 2.5 years post initial left tka, this 68 y/o female patient had a revision due to chronic hydrarthrosis occurring after somewhat prolonged walks.Patient was slightly lax, surgeon explained to patient, until proven otherwise, that synovectomy is necessary with replacement of a slightly thicker insert (13 vs 11mm).The wear marks on the center cam foot were real but relatively unobtrusive.The synovial fluid was not very abundant, and it was perfectly clear.Patient was revised to exactech devices.There was no breakage of device or surgical delay/prolongation reported.Photos and x-rays received, the device was returned additional information received indicates that patient had pe issue and patient painful while walking.There was evidence of poly wear.No additional information.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.These devices are used for treatment not diagnosis.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 1, 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 14161187
• Report Number: 1038671-2022-00436
• Device Sequence Number: 14901719
• Product Code: JWH
• UDI-Device Identifier: 10885862173409
• UDI-Public: 10885862173409
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2022

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: 07/31/2021
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 1, 11MM
• Device Catalogue Number: 02-012-44-1011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2022
• Supplement Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female