MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 3.5 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	02-012-35-3513
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544)
Date of Event	03/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation, this patient had right knee replacement (b)(6)2017.She had right knee revision (b)(6)2023, approximately 5 years 10 months after their initial implantation.Postoperative diagnosis: failed right total knee polyethylene due to premature poly wear and poly recall with osteolysis and loosening of the femoral and tibial components.There was found to be a grossly loose femoral component with a loose tibial component with moderate amount of osteolysis on the back side of each component.There was no cement adherent to the femoral component.All of the cement remained on the distal femur.There was a mild amount of osteolysis behind the cement mantle.There was a severe amount of polyethylene wear within the tibial polyethylene and there was encapsulated polyethylene debris of the synovium.A complete synovectomy was performed.There was a well-fixed patellar component.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
Pending investigation.D10.Concomitants: (b)(6), 02-010-01-0335 - logic femoral ps cem right sz 3.5; (b)(6), 02-012-45-3525 - lgc tibial fit tray cem sz 3.5f / 2.5t; (b)(6), 200-02-32 - three peg patella 32mm; (b)(6), 204-34-02 - fluted stem extension 25l x 14 mm; (b)(6), 204-70-00 - tibial stem ext.Screw.
Additional Manufacturer Narrative
Recall number: z-0021-2022.1038671-2024-05043 this follow-up report is being submitted to relay additional and/or corrected information.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-05043.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.D10: concomitants: (b)(6) 02-010-01-0335 - logic femoral ps cem right sz 3.5.(b)(6) 02-012-45-3525 - lgc tibial fit tray cem sz 3.5f / 2.5t.(b)(6) 200-02-32 - three peg patella 32mm.(b)(6) 204-34-02 - fluted stem extension 25l x 14 mm.(b)(6) 204-70-00 - tibial stem ext.Screw.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and femoral loosening or due to inclusion of the polyethylene in the packaging recall.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 PS MOD INSRT SZ 3.5 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• 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 ; 3523782617
• MDR Report Key: 17043561
• Report Number: 1038671-2023-01203
• Device Sequence Number: 5044739
• Product Code: JWH
• UDI-Device Identifier: 10885862001863
• UDI-Public: 10885862001863
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2024

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
• Device Expiration Date: 01/13/2024
• Device Model Number: 02-012-35-3513
• Device Catalogue Number: 02-012-35-3513
• 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: 05/02/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2016
• 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; SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 52 YR
• Patient Sex: Female