MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR FEMORAL POR, RIGHT, SZ 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC CR FEMORAL POR, RIGHT, SZ 5
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377)
Date of Event	03/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant products: lgc tibial fit tray cem sz 5f / 5t (cat# 02-012-45-5050 / serial# (b)(6)).Logic tib insert impl crc, sz 5, 9mm (cat# 02-012-51-5009 / serial# (b)(6)).Three peg patella 38mm (cat# 200-02-38 / serial# (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, the 70 year old male patient had an initial right tka on (b)(6) 2020.The patient was revised on (b)(6) 2024 due to femur loosening, osteolysis and poly wear.Everything was removed and exchanged to a competitor's product.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.Photos and x-rays received.The devices are not available for evaluation due to disposed at hospital.
Additional Manufacturer Narrative
H3: the revision reported may have been the result of femoral loosening, osteolysis, and prosthesis wear.The aseptic (non-infected) femoral loosening was likely the result of an insufficient bond between the femoral component and the bone.Based on the images provided, there does not appear to be an excessive amount of wear on the articular surface of the insert.The deformation and/or wear does not appear inconsistent with being implanted.However, this cannot be confirmed because the devices were not returned for evaluation.H7: z-0021-2022.
Additional Manufacturer Narrative
H6: corrected health effect - clinical code, component code, investigation findings, and investigation conclusions.Manufacturer narrative updated: the revision reported may have been the result of femoral loosening, osteolysis, and prosthesis wear.The aseptic (non-infected) femoral loosening was likely the result of an insufficient bond between the femoral component and the bone.Based on the images provided, there does not appear to be an excessive amount of wear on the articular surface of the insert.The deformation and/or wear does not appear inconsistent with being implanted.However, this cannot be confirmed because the devices were not returned for evaluation.

• Brand Name: LOGIC CR FEMORAL POR, RIGHT, SZ 5
• 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: matt collins
• MDR Report Key: 19111897
• Report Number: 1038671-2024-00846
• Device Sequence Number: 20614944
• Product Code: JWH
• UDI-Device Identifier: 10885862158406
• UDI-Public: 10885862158406
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123687
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/18/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/14/2025
• Device Model Number: LOGIC CR FEMORAL POR, RIGHT, SZ 5
• Device Catalogue Number: 02-010-04-0350
• 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: Not provided
• Supplement Date Received by Manufacturer: 04/24/2024; 10/11/2024
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 05/01/2024; 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2020
• 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: 3 TROCAR, MOD. HEX 2PK.; GPS IMPLANT KIT V2.; HOLDING PIN MINI SHARP POINT 4 PK.; THREADED PIN SIZE 2.3 COLLARED (X2).; THREADED PIN SIZE 3.0 COLLARLESS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 90 KG