MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 2, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	204-22-09
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that approximately 117 months after a left total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear and loosening of the tibial component.Revision surgery operative notes were provided.Postoperative diagnosis noted loose left knee tibial component.Intraoperatively two wound cultures were sent off with no infection appreciated and culture results were unremarkable.It was noted that the surgeon elected do the tibial revision and not the whole knee.It was noted that the tibial component was significantly loose.Patient was revised to exactech devices.No medical or surgical interventions were reported.No additional information is available the serial number (b)(6) is confirmed to be a part of recall number: z-0019-2022 204-22-09 - ps tibial inserts sz 2, 9mm serial: (b)(6)510k: k933610 udi: (b)(4)' product code: jwh x-ray: no operative notes: yes.
Additional Manufacturer Narrative
D10: concomitant devices: (b)(6) 234-02-02 - optetrak asy,ps cemented femoral, sz 2, (b)(6) 200-04-22 - cemented finned tib.Tra sz 2f/2t (b)(6) 200-02-29 - three peg patella 29mm the product associated with the reported event is within the scope of recall z-0019-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and tibial loosening.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 and radiographs were not provided.H6: corrected health effect and investigation clinical codes.

• Brand Name: PS TIBIAL INSERTS SZ 2, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21137666
• Report Number: 1038671-2025-00202
• Device Sequence Number: 15199259
• Product Code: JWH
• UDI-Device Identifier: 10885862048226
• UDI-Public: 10885862048226
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/04/2017
• Device Catalogue Number: 204-22-09
• 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: 11/09/2023
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 06/03/2025
• Date Device Manufactured: 05/05/2009
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male