MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 2, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	PS TIBIAL INSERTS SZ 2, 13MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Synovitis (2094)
Date of Event	02/18/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 11 years post initial right tka, this female patient underwent revision due to debris synovititis.No additional information is available or forthcoming.The device is not available for evaluation.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
As reported, approximately 11 years post initial right tka, this female patient underwent revision due to debris synovitis.No additional information is available or forthcoming.The device is not available for evaluation.Upon review of the available information, there is no evidence that this is a device related problem and no allegation against the device.Implantation of a total joint could result pain, infection, loosening of total joint hardware and the patient should monitor their activity and stresses to the operated knee.The most likely cause of the reported event is patient¿s conditions.**synovitis of the knee occurs when the synovial membrane becomes irritated and swells, causing discomfort or pain during joint movement.This condition may be caused by an underlying condition, such as arthritis, or by overuse of the joint.

• Brand Name: PS TIBIAL INSERTS SZ 2, 13MM
• 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: 13389206
• Report Number: 1038671-2022-00063
• Device Sequence Number: 11986375
• Product Code: JWH
• UDI-Device Identifier: 10885862048240
• UDI-Public: 10885862048240
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2022

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: 10/28/2016
• Device Model Number: PS TIBIAL INSERTS SZ 2, 13MM
• Device Catalogue Number: 204-22-13
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2022
• Supplement Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 01/28/2022
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2008
• 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 Sex: Female