MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 6, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	PS TIBIAL INSERTS SZ 6, 13MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Implant Pain (4561); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Joint effusion (4849)
Date of Event	05/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Procode: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Concomitants: 2754855 02-012-45-6060 - lgc tibial fit tray cem sz 6f / 6t.2977817 200-02-41 - three peg patella 41mm.3553937 204-34-04 - fluted stem extension 40l x 14 mm.3703978 204-70-00 - tibial stem ext.Screw.2057579 234-03-06 - optetrak asy,ps cemented femoral, sz 6.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported via legal notification, that patient, underwent initial right knee replacement surgery on (b)(6) 2014 and was implanted with a optetrak device.Specifically, plaintiff was implanted with a optetrak posterior stabilized tibial insert, along with an optetrak stem, optetrak patella, optetrak screws, a optetrak tibial tray, and a optetrak posterior stabilized femoral component.Following the surgery, plaintiff began experiencing worsening symptoms, pain, instability, effusion, and antalgic gate.Plaintiff underwent a right knee revision surgery on (b)(6) 2020, approximately 5 years 5 months post initial procedure.Plaintiff continues to experience pain and discomfort on a daily basis in his left knee which limits his daily activities and quality of life.No device return anticipated due to this being a legal case.No further information.
Additional Manufacturer Narrative
Additional information: a2, a3, b5, b7.
Event or Problem Description
Additional information received by the legal department on 16 feb 2023 [operative report and revision operative report/relevant information]: initial implant: the patient was taken to the recovery room awake and in good condition after dressings were applied.Revision operative report-preoperative diagnosis: failed right total knee arthroplasty.Findings: massive osteolysis, loose tibial component.There was a tremendous amount of fluid about the knee consistent with known particulate disease and synovitis.There was osteolysis about the femoral implant, there was an are tunneling into the posterolateral femoral condyle, this was debrided.The tibia was grossly loose with a large defect within the medial tibia.There was additional bone loss posterolaterally which created a cortical defect in the posterolateral through which muscle came through.The medial side was absent good bone.The patella was grossly loose and was removed.¿the patient was taken to the postanesthesia care unit in stable condition.He tolerated the procedure well.There were no immediate complications.¿ there is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
H6 - investigation results - the revision reported was likely the result of prosthesis wear, osteolysis, and insufficient bonds between the devices and the bones, which led to aseptic (non-infected) loosening.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.It is possible that a contributing factor to the reported wear may have been the result of being packaged in a non-conforming bag for more than 5 years before it was implanted.The extent and root cause of the osteolysis, loosening, and prosthesis wear could not be determined as the devices were not returned for evaluation, and images and radiographs were not provided.
Additional Manufacturer Narrative
The following sections were updated: g3/g4, h6 the following sections were corrected: d1/d2a/d2b, h6 mdr section codes updated/corrected: a, b, c, e the reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, tibial loosening, and patellar loosening.Or due to inclusion of the polyethylene in the packaging recall.Additionally, a contributing factor to the reported wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.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.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 6, 13MM
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16372929
• Report Number: 1038671-2023-00155
• Device Sequence Number: 17869450
• Product Code: JWH
• UDI-Device Identifier: 10885862048554
• UDI-Public: 10885862048554
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• 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
• Report Date (Section B): 01/28/2025

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: 09/18/2016
• Device Model Number: PS TIBIAL INSERTS SZ 6, 13MM
• Device Catalogue Number: 204-26-13
• 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: 01/20/2023
• Supplement Date Received by Manufacturer: 02/16/2023; 11/06/2023; 01/27/2025
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 03/27/2023; 11/14/2023; 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2008
• 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: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male