MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 3 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	02-012-35-3015
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Unspecified Tissue Injury (4559); Aseptic loosening (4883)
Date of Event	09/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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, insufficient information.Concomitant device(s): 02-010-01-0330 - logic femoral ps cem right sz 3 2625341, 02-012-45-3020 - lgc tibial fit tray cem sz 3f / 2t 2616531, 13a2101 - cemex system fast genta 70g aa6828, 200-02-32 - three peg patella 32mm 2725158.
Event or Problem Description
It was reported via legal notification that this 63 yo female patient's knee was revised 7 years post op.No other information available.
Additional Manufacturer Narrative
Additional information - b1, d8, & h6 medical device problem code.Pending investigation.There is no other information available.
Event or Problem Description
The patient has filed a short-form complaint in a multi-district litigation titled in re: exactech polyethylene orthopedic products liability litigation, mdl no.3044, and pending in the eastern district of new york.Per the transfer order creating this multi-district 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 multi-district litigation, the patient appears to allege that the patient was injured as a result of premature wear of an exactech polyethylene device.Patient revised to competitor's devices.Patient required revision surgery for issues including but not limited to polyethylene wear, instability, bone loss, and component loosening.¿ failed right tka.¿ ¿radiographs were taken and she was evaluated i the office and found to have likely a loose tibial component.¿ given that there was instability of the femoral and tibial i did decide that a full revision will be necessary also given her loosening of the tibia.¿ revision operative report provided was incomplete.There is no other information available.
Additional Manufacturer Narrative
H10.Updated/additional information ¿ g1.G2.G4.H6.The revision reported may have been the result of polyethylene wear, osteolysis and tibial loosening as stated in the legal documentation.The aseptic (non-infected) tibial loosening was likely the result of an insufficient bond between the tibial tray and the bone and patient-related conditions.However, this cannot be confirmed as the devices were not returned for evaluation.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.The extent and root cause of the reported polyethylene wear and osteolysis cannot be determined as the devices were not available for evaluation and pre-revision radiographs and images of the explanted devices were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b5, d8, e1, e2, e3, g1, h6 - health effect clinical code, component code, type of investigation, investigation findings and h7.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
It was reported that the patient underwent an initial right total knee arthroplasty.Subsequently, the patient experienced pain, ambulation difficulties, instability, tibial loosening and wear of the tibial insert.As a result, the patient underwent a right knee revision approximately 7 years and 2 months after initial implantation.The patient was last known to be in stable condition.No additional information available.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 3 15MM
• 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: ashley harris ; 3523771140
• MDR Report Key: 15535784
• Report Number: 1038671-2022-01224
• Device Sequence Number: 5212216
• Product Code: JWH
• UDI-Device Identifier: 10885862001832
• UDI-Public: 10885862001832
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/05/2026

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: 05/25/2018
• Device Model Number: 02-012-35-3015
• Device Catalogue Number: 02-012-35-3015
• 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: 09/13/2022
• Supplement Date Received by Manufacturer: 07/24/2023; 05/13/2024; 02/27/2026
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 08/24/2023; 05/15/2024; 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2010
• 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: 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; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female