MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 3.5 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-3511
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	08/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this 79 y/o female patient's left knee was revised approximately 10 months post op.Everything was revised due to wear on patella and tibial insert + the femur ¿debonded¿ from the cement.Diagnosis: loosening, lysis osteo, tibial & patella wear.Patient was last known to be in stable condition following the event.Product not returning: disposed.
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): (b)(6) 521-78-23 - threaded pin size 2.3 collared.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h3: the reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A review of manufacturing data was performed and no discrepancies were found.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 be the result of prosthesis wear of the patella as reported, patient-related issues, loosening or due to inclusion of the polyethylene in the packaging recall.The patella was confirmed to have a single pit, likely from a third-body, in the provided images; however overall, the patella and tibial insert are unremarkable for implanted devices.This cannot be confirmed as the devices were not returned for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 3.5 11MM
• 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20177095
• Report Number: 1038671-2024-03391
• Device Sequence Number: 12836784
• Product Code: JWH
• UDI-Device Identifier: 10885862001856
• UDI-Public: 10885862001856
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 02-012-35-3511
• 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: 08/22/2024
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 12/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2021
• 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
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 91 KG