MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 2.5 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	LOGIC TIBIA PS MOD INSRT SZ 2.5 11MM
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Ambulation or Postural Difficulties (2544); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via a legal tolling agreement, that a female patient, initial right knee implanted on (b)(6) 2017, underwent a revision procedure on (b)(6) 2020 approximately 2 years 11 months post the initial implant procedure for unknown reasons.No additional information is 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, insufficient information.
Additional Manufacturer Narrative
No device return anticipated due to this being a legal case.Concomitant medical products: 02-010-01-0325 - logic femoral ps cem right sz 2.5 sn: (b)(4), 02-012-45-2525 - lgc tibial fit tray cem sz 2.5f / 2.5t sn: (b)(4), 200-07-29 - advanced patella 29m 3 peg implant sn: (b)(4), 201-78-82 - collar fixation pin 2pk 40mm, quick release sn: (b)(4).
Additional Manufacturer Narrative
A2: added d.O.B.B3: corrected date of event.D6a,d6b: corrected implant/explant dates.H6: updated clinical codes: 1994 and 1924.
Event or Problem Description
It was reported via legal documentation that approximately 36 months after a right total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, femoral debonding and pain.Initial surgery and revision surgery operative notes were provided.Post operative diagnosis noted wear of the tibial component and loosening of the femoral component.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
B5: updated description of event.H6: added 2 clinical codes; corrected medical device problem and component codes.Corrected type of investigation, investigation findings and investigation conclusion codes.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g3/g4, h6.The following sections were corrected: h6.Mdr section codes updated/corrected: b, c, d, e.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 2.5 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
• 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: 15395407
• Report Number: 1038671-2022-01087
• Device Sequence Number: 20382920
• Product Code: JWH
• UDI-Device Identifier: 10885862001771
• UDI-Public: 10885862001771
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/10/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/17/2022
• Device Model Number: LOGIC TIBIA PS MOD INSRT SZ 2.5 11MM
• Device Catalogue Number: 02-012-35-2511
• 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: 08/12/2022
• Supplement Date Received by Manufacturer: 10/24/2022; Not provided; Not provided; 01/09/2025
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 10/24/2022; 11/19/2024; 12/09/2024; 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2014
• 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
• Patient Age: 74 YR
• Patient Sex: Female