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

Model Number	N/A
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582); Aseptic loosening (4883)
Date of Event	09/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device return anticipated due to this being a legal case.(b)(4).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported via a legal notification that a female patient, initial left knee implanted on (b)(6) 2011, underwent a revision procedure on (b)(6) 2022, approximately 11 years 1 month post the initial implant procedure for reasons unknown.No further information was reported.
Additional Manufacturer Narrative
H6: based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined, insufficient information.
Additional Manufacturer Narrative
H3: the revision reported in the case was likely the result of polyethylene wear as stated in the legal documentation.The extent and root cause of the polyethylene wear cannot be determined as the device was not available for evaluation and radiographs, photographs, or operative notes were not provided.
Event or Problem Description
As reported via additional legal documentation, on (b)(6) 2011, the patient underwent left knee replacement surgery where she was implanted with an optetrak ps polyethylene tibial insert serial #: (b)(6).On (b)(6) 2022, approximately 11 years 1 month after their initial surgery, they underwent left knee revision surgery to remove the failed polyethylene liner due to accelerated and preventable wear of the polyethylene tibial insert.
Additional Manufacturer Narrative
Additional information added.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6.

• Brand Name: PS TIBIAL INSERTS
• 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 ; 3523771140
• MDR Report Key: 15504530
• Report Number: 1038671-2022-01208
• Device Sequence Number: 18104946
• Product Code: JWH
• UDI-Device Identifier: 10885862048264
• UDI-Public: 10885862048264
• 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: 2011
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/08/2026

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: 05/16/2019
• Device Model Number: N/A
• Device Catalogue Number: 204-22-18
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2022
• Supplement Date Received by Manufacturer: 09/28/2022; 08/14/2023; 10/18/2023; 04/17/2026
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 10/25/2022; 09/12/2023; 10/18/2023; 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2011
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0019-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female