MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM RIGHT SZ 3.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	02-010-01-0335
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	07/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.02-012-44-3511 - logic tibia implant psc insert, sz 3.5, 11mm 2719392, 02-012-45-3525 - lgc tibial fit tray cem sz 3.5f / 2.5t 3594472, 200-02-35 - three peg patella 35mm 3808594.
Event or Problem Description
As reported, this 61 year old female patient had an initial right tka on (b)(6) 2015.The patient complained of pain and was revised due to a loose femur.The patient was last known to be in stable condition following the event.The device(s) are not returning as the hospital refuses to release them.
Additional Manufacturer Narrative
According to the information provided, this 62 y/o female patient received a right total knee replacement on (b)(6)2015.Approximately 7.5 years after the index surgery, the patient was allegedly revised on (b)(6)2022 due to femoral loosening.However, the revision surgery data provided shows femoral components were not invoiced for the revision surgery.Therefore, it appears that this patient may have not been revised for femoral loosening.Multiple attempts were made to retrieve additional information from two different sales representatives to clarify this discrepancy, but no additional information for this revision was received.The explanted devices were not available for evaluation due to hospital policy and images of the explanted devices/pre-revision radiographs were unable to be obtained.Due to the minimal/conflicting information provided, the reason for revision and contributions of design, manufacturing, patient conditions, and/or user-related issues to the reported event cannot be determined.Additionally, a review of the risk management files cannot be conducted because adequate information was not provided to conduct a review.The patient was last known to be in stable condition following the revision surgery.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, f6, f9 (remove erroneous entries from initial report), g3 (correct initial report to 26-jul-2022, h6: clinical code, component code, type of investigation and investigation findings.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC FEMORAL PS CEM RIGHT SZ 3.5
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15165504
• Report Number: 1038671-2022-00874
• Device Sequence Number: 4652260
• Product Code: JWH
• UDI-Device Identifier: 10885862001245
• UDI-Public: 10885862001245
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/15/2026

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: 09/15/2019
• Device Model Number: 02-010-01-0335
• Device Catalogue Number: 02-010-01-0335
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/12/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2022
• Supplement Date Received by Manufacturer: 06/30/2023; 04/09/2026
• Initial Report FDA Received Date: 08/04/2022
• Supplement Report FDA Received Date: 07/12/2023; 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2014
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Female