MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM LEFT SZ 2; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	LOGIC FEMORAL PS CEM LEFT SZ 2
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Abdominal Pain (1685); Failure of Implant (1924); Osteolysis (2377); Implant Pain (4561); Joint effusion (4849)
Date of Event	11/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 67 yo female, initial left knee implanted on (b)(6) 2010, underwent a revision procedure on (b)(6) 2022, approximately 12 years post the initial procedure.The patient complained of pain.Loose femur indicated.Patient was last known to be in stable condition following the event.The product is not returning due to chain of custody.Due to the recall the hospital will not release implants.No further information known.
Additional Manufacturer Narrative
Concomitants medical devices: recall device - 1756506, 02-012-35-2015 - logic tibia ps mod insrt sz 2 15mm, 1753187, 02-012-41-2020 - logic tibia traptray cem sz 2f/2t, 1864054, 200-02-35 - three peg patella 35mm.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After review of additional information received the following sections, have been updated accordingly: h6: the revision reported was likely the result of a degradation of the bond between the femoral component and the bone, patient-related conditions, longevity of the implanted device, or any combination of these possibilities, which led to aseptic (non-infected) femoral loosening.The loosening may have led to instability and an increase in cement and bone particles in the joint space and resulted in prosthesis wear.However, this cannot be confirmed as the devices were not available for evaluation and pre-revision radiographs were unable to be obtained.
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: d1/d2a/d2b, h6.Mdr section codes updated/corrected: a, b, c, d, g.The reason for the revision reported cannot be confirmed from the information provided but may be the result of loosening and prosthesis wear or due to inclusion of the polyethylene in the packaging recall.Failure of the cement used to secure the femoral component to the femoral bone, may have lead to loosening at the cement-implant interface; however, this cannot be confirmed.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available 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.

• Brand Name: LOGIC FEMORAL PS CEM LEFT SZ 2
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15920916
• Report Number: 1038671-2022-01563
• Device Sequence Number: 4397490
• Product Code: JWH
• UDI-Device Identifier: 10885862001122
• UDI-Public: 10885862001122
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2025

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: 08/15/2015
• Device Model Number: LOGIC FEMORAL PS CEM LEFT SZ 2
• Device Catalogue Number: 02-010-01-0220
• 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: 11/07/2022
• Supplement Date Received by Manufacturer: 03/13/2023; 01/14/2025
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 03/21/2023; 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2010
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female