MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 3, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	204-23-13
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	03/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.H10: optetrak 3 peg patella 29mm - 200-02-29 - 2161439; optetrak tibial tray, cemented sz 3f/3t - 204-04-33 - 2167036; optetrak ps femoral, cemented size 3 left - 234-02-03 - 2150806.H7: z-0019-2022.
Event or Problem Description
As reported, the patient had an initial left tka on (b)(6) 2012.The patient had a poly and patella revision on (b)(6) 2023 due to the components being loose and worn.Parts and pieces fell into the patient wound site and were removed by the surgeon.Fragments of polyethylene were present in the knee joint.There was a 5-15 minute surgical delay.The patient did not experience any adverse events a result of the delay.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of prosthesis wear of the tibial insert and patella possibly due to malalignment between the implants, high contact stresses during knee flexion/extension, third body wear, patient-related conditions, instability, or any combination of these possibilities.The cause of the prosthesis wear and reported loosening cannot be determined because the revised components were not returned for evaluation and no radiographs were provided.An additional contributing factor to the revision may have been inclusion of the implanted tibial insert in the packaging recall.

• Brand Name: PS TIBIAL INSERTS SZ 3, 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16843377
• Report Number: 1038671-2023-00867
• Device Sequence Number: 17857671
• Product Code: JWH
• 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: 2012
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/09/2018
• Device Model Number: 204-23-13
• Device Catalogue Number: 204-23-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2023
• Supplement Date Received by Manufacturer: 06/21/2023; 09/15/2026
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 07/05/2023; 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2010
• 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 H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female