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 Code	Failure of Implant (1924)
Date of Event	10/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had an initial left tka on (b)(6) 2010.The patient complained of pain and was revised on (b)(6) 2023 due to a loose femur and recalled poly.The patient was revised to exactech devices.There was no reported breakage of device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
H3: pending investigation.D10: 1487932 02-012-35-3009 - logic tibia ps mod insrt sz 3 9mm 1664846 02-012-41-3030 - logic tibia.Traptray cem sz 3f/3t 1707906 200-02-35 - three peg patella 35mm.1789213 200-02-35 - three peg patella 35mm.Unknown which patella was implanted.H7: z-0021-2022 for 1487932 02-012-35-3009 - logic tibia ps mod insrt sz 3 9mm.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of prosthesis wear of the patella and tibial insert, and aseptic (non-infected) femoral loosening, after being implanted for more than 13 years.The femoral loosening may have been the result of degradation of the bond between the femoral component and the bone, patient-related conditions, or any combination of these possibilities.However, this cannot be confirmed as the devices were not returned to exactech for evaluation.

• 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: kate jacobson ; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17964808
• Report Number: 1038671-2023-02567
• Device Sequence Number: 6565774
• Product Code: JWH
• UDI-Device Identifier: 10885862001146
• UDI-Public: 10885862001146
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2023

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: 03/10/2015
• Device Catalogue Number: 02-010-01-0230
• 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: 10/03/2023
• Supplement Date Received by Manufacturer: 11/06/2023
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 11/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2010
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female