MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT; SEE H10

Catalog Number	02-012-44-2013
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Balance Problems (4401); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via a legal notification that a patient, initial right knee implanted on (b)(6) 2009, underwent a revision procedure on (b)(6) 2011, in which the optetrak logic tibial inserts made of polyethylene were removed and replaced with another optetrak device.The plaintiff received a letter in or around april of 2022 informing her that her optetrak device had been recalled.Upon information and belief, as a result of the 2011 optetrak device failing, the plaintiff underwent another revision surgery on her right knee on (b)(6) 2022, approximately 10 years 7 months post the 2011 revision procedure for issues including but not limited to polyethylene wear, bone loss, osteolysis, and/or component loosening.The plaintiff experiences daily pain and discomfort in her knee which limits her activities of daily living and impacts her quality of life.No device returns anticipated due to this being a legal case.No further information.First revision reported under 1038671-2023-00278.
Additional Manufacturer Narrative
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H3: based on review of all available information, there is no evidence or report to suggest that the event is related to failure of the device to meet specifications, devices are inspected before they are released for distribution.Device information was not provided.The cause of the patient's condition and revision surgery as related to the devices cannot be conclusively determined, insufficient information.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
Additional information - a2, a3, b1 prob, b5, b6, d1, d4 all, g4 510k, h4, h6 health effect - clinical code & medical device problem code, h7 & h9.The new information requires a new investigation.Pending investigation.No other information is available.
Event or Problem Description
Additional information received from legal department revision operative report of 30 jun 2022 - postoperative diagnosis: osteolysis status post right total knee replacement, wear of articular bearing, instability, recurrent effusions.Findings: severe osteolysis of the femur centrally with remaining epicondyles and struts of supportive bone in lateral and medial condyle iib bone loss.Osteolysis tibia iia bone loss.Osteolysis severe of the patella involving lateral facet with remaining eggshell of bone, not enough to support revision resurfacing components.Extensive synovitis consistent with poly wear and osteolysis.No evidence of infection.Implants not grossly loose.Severe poly wear with delamination.The patient was transferred to the recovery room in stable condition.Post-operative plan: the patient will be allowed to weight-bear as tolerated.They will receive perioperative antibiotics, asa, and mechanical compression devices for dvt prophylaxis.They will be discharged home from the hospital when they are comfortable and have met all pt goals.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear or due to inclusion of the polyethylene in the packaging recall.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.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.H6: corrected health effect, component, and investigation clinical codes.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT
• 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: kate jacobson ; 3523771140
• MDR Report Key: 16457471
• Report Number: 1038671-2023-00278
• Device Sequence Number: 12405352
• Product Code: JWH
• UDI-Device Identifier: 10885862173492
• UDI-Public: 10885862173492
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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,Followup
• Report Date (Section B): 11/08/2024

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: 07/20/2019
• Device Catalogue Number: 02-012-44-2013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2023
• Supplement Date Received by Manufacturer: 02/06/2023; 05/31/2023; 11/08/2024
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 05/30/2023; 06/22/2023; 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2011
• 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
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female