MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT; SEE H10

Model Number	SPECIFIC DEVICE NOT REPORTED
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	06/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Procode: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.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 a patient, underwent a bilateral knee replacement initial surgery on (b)(6) 2014.The patient was implanted with a optetrak devices.Specifically, implanted with a optetrak posterior stabilized tibial insert, along with optetrak stems, optetrak patellas, optetrak screws, optetrak tibial trays, and optetrak posterior stabilized femoral components.Following the surgery, the patient began experiencing worsening symptoms, pain, instability, effusion, and antalgic gate.The patient underwent a right knee revision surgery on (b)(6) 2022, approximately 8 years post initial procedure and was implanted with a different device.The patient continues to experience pain and discomfort on a daily basis in both of her knees which limits her daily activities and quality of life.No device return anticipated due to this being a legal case.No further information.
Event or Problem Description
Additional information received via legal department-revision for right total knee arthroplasty on (b)(6) 2022.Preoperative diagnosis- failed right total knee arthroplasty secondary to polyethylene wear.Findings: broken post and delaminated polyethylene insert/grossly loose femoral component.73 yo female.Physical examination and imaging studies were consistent with aseptic failure due to polyethylene wear.The femoral component was loose.The posterior stabilized post was fractured.The fracture tip was identified and removed.There were pieces of polyethylene that were encountered during the case and were removed and saved with the final specimen.Soft tissue was sent for permanent culture and pathology.It was apparent that the femoral component was grossly loose and was removed by hand.There was some bone loss both distally and posteriorly but nothing excessive.The patella was inspected and found to be in good condition and compatible.A sterile dressing was applied, she was awakened and extubated.She tolerated the procedure well and there were no known complications and taken to the recovery room in stable condition.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
Additional information: a2, a3, b1, b5, b7, d1, d4 all, d10, g4 510k, h6 medical device problem code, h7, h9 d10.Concomitants: (b)(6), 203-90-03 - 11-3978 stablecut gts osc system 6105x19x1.27, (b)(6), 02-010-01-0310 - logic femoral ps cem right sz 1, (b)(6), 203-96-41 - (11-3974) stryker sys 6 90x13x1.27, (b)(6), 02-012-41-1010 - logic tibia traptray cem sz 1f/1t, (b)(6), 200-02-29 - three peg patella 29mm, (b)(6), 204-32-01 - fluted stem extension 11l x 12 mm, (b)(6), 201-78-15 - holding pin mini sharp point 4 pk, (b)(6), 204-70-00 - tibial stem ext.Screw, (b)(6), 201-78-81 - 3" trocar, mod.Hex 2pk, (b)(6), 201-78-81 - 3" trocar, mod.Hex 2pk, (b)(6), 203-96-42 - 11-4132 stryker sys 6 90x13/21x1.19.
Additional Manufacturer Narrative
The revision reported was likely the result of polyethylene wear, prosthesis fracture, and femoral loosening as stated in the legal documentation.The aseptic (non-infected) femoral loosening may have been the result of an insufficient bond between the femoral component and/or patient-related conditions.The extent and root cause of the polyethylene wear, prosthesis fracture, and femoral loosening cannot be determined as the devices were not available for evaluation, and radiographs and photographs were not provided with the submission.

• Brand Name: LOGIC TIBIA PS MOD INSRT
• Common Device Name: SEE H10
• 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: matt collins ; 3523771140
• MDR Report Key: 16368737
• Report Number: 1038671-2023-00141
• Device Sequence Number: 7543761
• Product Code: JWH
• UDI-Device Identifier: 10885862001696
• UDI-Public: 10885862001696
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2024

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: 02/02/2025
• Device Model Number: SPECIFIC DEVICE NOT REPORTED
• Device Catalogue Number: 02-012-35-1011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2023
• Supplement Date Received by Manufacturer: 03/13/2023; 04/12/2024
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 04/12/2023; 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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-0021-2022
• 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