MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 2, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	204-22-11
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Insufficient Device Problem Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377); Implant Pain (4561); Joint effusion (4849)
Date of Event	07/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by legal, approximately 14 years post op the initial left tka, this female patient was revised.Reason for revision was not reported.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.
Additional Manufacturer Narrative
H3: investigation results: the revision reported was likely the result of prosthesis wear and osteolysis.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 could not be determined from the information provided whether the reported backside wear was the result of incomplete seating of the tibial insert or loosening of the insert within the tray.The extent and root cause of the prosthesis wear and osteolysis could not be determined as the devices were not returned for evaluation, and images and radiographs were not provided.
Additional Manufacturer Narrative
H10.Additional/updated information ¿ b1, b5, b6, b7, d8, h6 health effect - clinical code, medical device problem code, h7, & h9.There is no other information available.These devices are used for treatment not diagnosis.Pending investigation.
Event or Problem Description
Revision operative of 15 jul 2022-patient was revised to competitor¿s devices.Preoperative diagnosis: global instability status post left total knee replacement, recurrent effusions and pain.Procedure(s): revision left total knee replacement, both components.Findings: global instability under anesthesia with 5 deg hyperextension, med/lat laxity in extension mid flexion and flexion with 1 cm ap translation.Post wear.Components well fixed.Aori type i bone loss tibia and type i bone loss femur.No gross evidence of infection.Loose poly insert within the tray consistent with backside wear.Procedure: synovectomy was performed.The patella was found to be well fixed and so was retained due to morbidity of removal.The size 11 mm ps polyethylene insert was found to be loose on the tray and there was severe wear of the post.The femoral component was found to be well fixed; the component was then removed using a bone tamp with minimal bone loss.Removal of the femoral component revealed aori type i bone loss.The tibial component was found to be well fixed; the tibial component was then removed.Bony inventory of the tibia revealed aori type i bone loss.There was excellent supportive bone for tibial component and so a cone was not needed.Devices were trailed and then implanted.Dressings were applied.There were no complications.The patient was transferred to the recovery room in stable condition.Patient discharged home from the hospital when comfortable and have met all pt goals.There is no device return, there are no provided images, there is no other information available.
Additional Manufacturer Narrative
Additional information: h6 clinical code, problem code.Correction: h6 component code.

• Brand Name: PS TIBIAL INSERTS SZ 2, 11MM
• 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 ct; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 3523771140
• MDR Report Key: 16783990
• Report Number: 1038671-2023-00785
• Device Sequence Number: 5781502
• Product Code: JWH
• UDI-Device Identifier: 10885862048233
• UDI-Public: 10885862048233
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/13/2024

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: 04/15/2016
• Device Catalogue Number: 204-22-11
• 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: 03/31/2023
• Supplement Date Received by Manufacturer: 11/29/2023; 02/08/2024; 08/21/2024
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 11/29/2023; 02/13/2024; 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2008
• 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
• Patient Sex: Female