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
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	10/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 02-012-35-2013 - logic tibia ps mod insrt sz 2 13mm, (b)(6); 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t, (b)(6); 200-02-29 - three peg patella 29mm, (b)(6); 204-34-02 - fluted stem extension 25l x 14 mm, (b)(6); 204-70-00 - tibial stem ext.Screw, (b)(6).The product associated with the reported event is within the scope of recall z-1413-2024; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Event or Problem Description
Legal case-usa: it was reported via legal documentation that a patient had a left total knee arthroplasty on (b)(6) 2017, and then experienced revision surgical procedure on (b)(6) 2023 approximately 6 years and 8 months after initial implant.No images were provided.There is no other information available.No device return anticipated due to this being a legal case.Ebi initial surgery attached.Historical record & smartsolve searched for sn/patient name with no results.Operative report from revision surgery attached.No further information.As directed by qa management: this legal complaint case is from the united states.The event did not occur in, nor is it reportable for brazil, canada, eea/eu, japan, taiwan, or great britain, excluding northern ireland.Therefore, only the us reportability determination will be assessed.

• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 20864614
• Report Number: 1038671-2024-04663
• Device Sequence Number: 20988120
• Product Code: JWH
• UDI-Device Identifier: 10885862001122
• UDI-Public: 10885862001122
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2024

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: 08/18/2021
• Device Model Number: LOGIC FEMORAL PS CEM LEFT
• Device Catalogue Number: 02-010-01-0220
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 12/06/2024
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female