MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 2.5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC TIB INSERT IMPL CRC, SZ 2.5, 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported by the legal team, approximately seven years post initial tka, this (b)(6) female patient is expected to have a revision surgery on (b)(6) 2022 in order to replace the eroded exactech artificial cartilage (plastic tibial insert).The patient was initially diagnosed with osteopenia and since her initial surgery experienced numerous symptoms, including pain, swelling, difficulty walking, and waking at night due to knee pain.These symptoms started a couple of years after the surgery.The symptoms have slowly and steadily worsened.Patient mentioned that at first, "she found that she could not walk on pavement without pain and swelling that lasted afterward for hours.Then, she began to have the same symptoms after walking on smooth dirt paths in the woods".
Additional Manufacturer Narrative
(h3) the revision reported was likely the result of the patient¿s pain, which may have been due to prosthesis wear of the tibial insert related to third body wear and/or patient-related conditions.The most probable root cause associated with the reported event of "prosthesis wear¿ is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.

• Brand Name: LOGIC TIB INSERT IMPL CRC, SZ 2.5, 9MM
• 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 ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 13944807
• Report Number: 1038671-2022-00311
• Device Sequence Number: 6701805
• Product Code: JWH
• UDI-Device Identifier: 10885862230362
• UDI-Public: 10885862230362
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K123342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2022

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 Model Number: LOGIC TIB INSERT IMPL CRC, SZ 2.5, 9MM
• Device Catalogue Number: 02-012-51-2509
• 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: 03/08/2022
• Supplement Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: - LGC TIBIAL FIT TRAY CEM SZ 2.5F / 2.5T; - LOGIC CR FEMORAL CEM, RIGHT, SZ 2.5; - THREE PEG PATELLA 35MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female