MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 3 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	LOGIC TIBIA PS MOD INSRT SZ 3 9MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Metal Related Pathology (4530); Swelling/ Edema (4577)
Date of Event	01/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product associated with the reported event is within the scope of recall z-0021-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.D10 concomitants: (b)(6), 02-012-39-3020 - logic tibia fin tray cem sz 3f/2t, (b)(6), 02-010-01-0330 - logic femoral ps cem right sz 3, (b)(6), 200-02-32 - three peg patella 32mm.
Event or Problem Description
Legal case ¿ usa (b)(4) patient id: right knee.9/23/24: additional information received in in-box on 9/16/24.Attached email and legal short form.The patient has filed a short-form complaint in a multidistrict litigation titled in re: exactech polyethylene orthopedic products liability litigation, (b)(4), and pending in the (b)(6).Per the transfer order creating this multidistrict litigation, ¿plaintiffs.Allege that their knee or hip replacement devices¿failed prematurely because of degradation of the device¿s polyethylene component which resulted in the premature removal (or planned removal) of the prosthesis at issue.¿ because the patient has filed a suit in this multidistrict litigation, the patient appears to allege that the patient was injured as a result of premature wear of an exactech polyethylene device.As reported via legal documentation, a patient had right knee replacement surgery on (b)(6) 2010.They underwent right knee revision surgery on (b)(6) 2023, approximately 12 years 7 months post primary procedure.Revision op report states that the knee was grossly unstable in all planes through the range of motion.The synovium was black from metal debris.The femoral component was well fixed and aligned/sized appropriately.The tibial implant was loose.The right tibial component was shifted into excessive posterior slope to motion of the implant and osteolysis at the fixation interface.The patellar implant was intact without significant wear and remained well fixed.The mcl was absent.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.Ebi initial surgery attached.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
As reported via legal documentation, a patient had right knee replacement surgery.They underwent right knee revision surgery approximately 12 years 7 months post primary procedure.Revision op report states that the knee was grossly unstable in all planes through the range of motion.The synovium was black from metal debris.The femoral component was well fixed and aligned/sized appropriately.The tibial implant was loose.The right tibial component was shifted into excessive posterior slope to motion of the implant and osteolysis at the fixation interface.The patellar implant was intact without significant wear and remained well fixed.The mcl was absent.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.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 3 9MM
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21211816
• Report Number: 1038671-2025-00347
• Device Sequence Number: 3851874
• Product Code: JWH
• UDI-Device Identifier: 10885862001801
• UDI-Public: 10885862001801
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2025

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: 03/19/2018
• Device Model Number: LOGIC TIBIA PS MOD INSRT SZ 3 9MM
• Device Catalogue Number: 02-012-35-3009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/14/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 03/12/2025
• Date Device Manufactured: 03/22/2010
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female