MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM LEFT SZ 3; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-01-0230
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6) 02-012-45-3030 - bandeja tibial logic fit 3f/3t.(b)(6) 204-34-04 - vastago ext.14x40mm.(b)(6) 204-70-00 - tornillo fijacion vástago a tibia.No device was returned for evaluation; photographs of the device were provided; however, the reported event was unable to be confirmed.The review identified that there appears to be minor pitting and scratching along the articular surface, consistent with implantation.Additionally, there appears to be minor damage along the anterior portion of the insert.However, the cause cannot be determined from the information provided.The tibial insert appears unremarkable for an explanted component.The femoral component appears to have debonded from the cement mantle.No information regarding the type of cement used, cementing technique, or operative conditions was provided for this case.Additionally, it is unknown if the femoral component had loosened from the cement prior to revision or if the femoral component was loosened from the cement mantle during the revision secondary to trial impactions to test component fixation and, if so, what amount of force was required to remove the femoral component.Operative notes and/or medical records were not provided for review of usage/ technique.A review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, may have resulted from femoral debonding and instability.The cause of the reported loosening cannot be conclusively determined but may be related to cement viscosity, cement technique, length of time between mixing and application of the cement, and/or impaction forces during the revision.However, loosening, instability, and the series of events cannot be confirmed and potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not returned for evaluation 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.
Event or Problem Description
As reported, the patient underwent an initial left total knee arthroplasty.Subsequently, the patient was revised due to pain and instability with no bone loss.The patient was revised to competitor devices.The patient started experiencing pain and inflammation since 2021.Additional information received indicated the femoral component was not osseointegrated to the bone.The component came loose by hand.

• Brand Name: LOGIC FEMORAL PS CEM LEFT SZ 3
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 24489205
• Report Number: 1038671-2026-00209
• Device Sequence Number: 10685588
• Product Code: JWH
• UDI-Device Identifier: 10885862001146
• UDI-Public: 10885862001146
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/02/2026

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: 01/12/2023
• Device Catalogue Number: 02-010-01-0230
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 03/02/2026
• Date Device Manufactured: 01/16/2018
• 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: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 81 KG