MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 2.5, 15MM; KNEE FEMORAL COMPONENTS

Model Number	LOGIC TIBIA IMPLANT PSC INSERT, SZ 2.5, 15MM
Medical Device Problem Codes	Material Fragmentation (1261); Unstable (1667); Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abdominal Pain (1685); Failure of Implant (1924); Pain (1994); Synovitis (2094); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	03/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported by the legal brief, on (b)(6) 2020, patient underwent a tka on her right knee and was implanted with an optetrak tka system.Patient's optetrak tka system subsequently failed in (b)(6) 2022-less than two (2) years after it was initially implanted.As a result, patient required an additional surgery to remove and replace it with another joint replacement system.Because patient required an additional revision surgery, patient has suffered significant and continuing personal injuries, is limited in her activities of daily living, requires additional physical therapy, and has incurred substantial medical bills and expenses.As a direct, proximate and result, patient has suffered and continues to suffer significant, permanent, and continuing personal injuries, as described herein.
Additional Manufacturer Narrative
After further review of additional information received the following sections d1, d4, d10, g3, g4, g6, h2, h3, h4, h6 and h9 have been updated accordingly.Section d10: concomitant medical products truliant ps cem fem ps cem right sz 2.5 (cat# 02-020-11-0325 / serial# (b)(6)).Truliant tib fit tray cem sz 2.5f / 2.5t (cat# 02-022-45-2525 / serial# (b)(6)).Three peg patella 35mm (cat# 200-02-35 / serial# (b)(6)).(h3) as reported by the legal brief, on (b)(6), 2020, patient underwent a tka on her right knee and was implanted with an optetrak tka system.Patient's optetrak tka system subsequently failed in (b)(6) 2022-less than two (2) years after it was initially implanted.As a result, patient required an additional surgery to remove and replace it with another joint replacement system because patient required an additional revision surgery.No additional information available.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.These devices are used for treatment not diagnosis.
Event or Problem Description
It was reported via legal documentation approximately 22 months after a right total knee replacement, the patient underwent a right knee revision surgery to address prosthesis wear, pain, swelling and instability.A revision operative report was provided.Post operative diagnosis noted failed right total knee replacement secondary to polyethylene wear.Intraoperatively, the surgeon observed synovitis and large fragments of polyethylene throughout the knee joint and was significantly worn both on the post and in the medial tibial plateau.It was noted that aspiration of the knee revealed non-infected synovial fluid.The revision procedure was tibial component with a polyethylene exchange.No surgical or medical interventions were reported.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Additional information fields: a2, a3, b5, d10, g, g2, h6 investigation codes.Corrected fields: b1, b3, d6a, d6b, h3, h6 clinical codes, health impact code, medical device problem codes and component codes.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.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, 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: LOGIC TIBIA IMPLANT PSC INSERT, SZ 2.5, 15MM
• Common Device Name: KNEE FEMORAL COMPONENTS
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 14645221
• Report Number: 1038671-2022-00658
• Device Sequence Number: 17536505
• Product Code: JWH
• UDI-Device Identifier: 10885862173546
• UDI-Public: 10885862173546
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/24/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/29/2020
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 2.5, 15MM
• Device Catalogue Number: 02-012-44-2515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2022
• Supplement Date Received by Manufacturer: 08/24/2022; 12/27/2023; 03/21/2025
• Initial Report FDA Received Date: 06/09/2022
• Supplement Report FDA Received Date: 09/24/2022; 02/18/2025; 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2012
• 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 H11.; UNK.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female