MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 3, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	PS TIBIAL INSERTS SZ 3, 15MM
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Pain (1994); Discomfort (2330); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device return anticipated due to this being a legal case.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.
Event or Problem Description
It was reported via a legal notification that a female patient, right knee implanted on (b)(6) 2008, underwent a revision procedure on (b)(6) 2016, approximately 7 years 11 months post the initial implant procedure for reasons unknown.No further information known.
Additional Manufacturer Narrative
If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: PS TIBIAL INSERTS SZ 3, 15MM
• 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: 15725959
• Report Number: 1038671-2022-01403
• Device Sequence Number: 16873805
• Product Code: JWH
• UDI-Device Identifier: 10885862048332
• UDI-Public: 10885862048332
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/06/2025

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: 05/15/2016
• Device Model Number: PS TIBIAL INSERTS SZ 3, 15MM
• Device Catalogue Number: 204-23-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2022
• Supplement Date Received by Manufacturer: 02/25/2025; 03/03/2025; 03/03/2025
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 02/26/2025; 03/04/2025; 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2008
• 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
• 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