MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 2, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	204-22-15
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Swelling/ Edema (4577); Insufficient Information (4580)
Date of Event	07/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a right total knee replacement procedure.The patient underwent a revision procedure to address a polyethylene wear.There was no reported surgical delay.Patient was last known to be in stable condition following the event.No further issues or complications were reported.No additional information is available.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
(h3) pending evaluation: (d10) concomitant device(s): 4028758 204-36-08 - stem extension 80l x16 mm.2862928 204-61-08 - tibial augment block 1/2-sz 1 8mm.2668430 208-04-22 - trap tray, offset beta cem sz 1f/1t & 2f/1t.
Additional Manufacturer Narrative
H3 the revision reported in case (b)(4) may have been the result of malalignment between the femoral and tibial components, instability, patient related factors, and/or any combination of these possibilities which led to prosthesis wear and fracture.However, this cannot be confirmed because the component was not returned for evaluation, and no radiographs were provided.Additionally, a contributing factor may have been being packaged in a non-conforming bag for more than five years.The following sections have corrected information: (h6) heath effect - clinical code.

• Brand Name: PS TIBIAL INSERTS SZ 2, 15MM
• 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19968829
• Report Number: 1038671-2024-02798
• Device Sequence Number: 21073412
• Product Code: JWH
• UDI-Device Identifier: 10885862048257
• UDI-Public: 10885862048257
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2024

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: 05/10/2019
• Device Catalogue Number: 204-22-15
• 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: 07/23/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2011
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female