MAUDE Adverse Event Report: EXACTECH, INC. LOGIC; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	LOGIC PS INSERT SZ 1.5, 13MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Synovitis (2094); Joint Laxity (4526); Implant Pain (4561)
Date of Event	10/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: (b)(4), 02-010-01-0215 - logic femoral ps cem left sz 1.5.(b)(4), 02-012-35-1513 - logic ps insert sz 1.5, 13mm.(b)(4), 02-012-45-1515 - lgc tibial fit tray cem sz 1.5f / 1.5t.(b)(4), 200-02-32 - three peg patella 32mm.(b)(4), 521-78-31 - threaded pin size 2.6 collarless 2pk.(b)(4), 521-78-31 - threaded pin size 2.6 collarless 2pk.(b)(4), 521-78-32 - threaded pin size 3.0 collarless 2pk.(b)(4), 521-78-36 - threaded pin size 5.1 collarless 2pk.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported a female patient, initial left knee implanted on (b)(6) 2017, underwent a revision procedure on (b)(6) approximately 5 years 8 months post the initial procedure.The patient presented with pain and synovitis.Mri did not show loose components per the surgeon.Aggravated tissue was removed, and a new ps poly was inserted.There was some laxity with the same 13mm ps so a 15mm insert was chosen.Good rom and stability were achieved.The surgeon noted significant wear.Patient left in stable condition.
Event or Problem Description
The revision reported may have been due to malalignment between the femoral and tibial components, fatigue wear, patient activity level, or any combination of these possibilities, which led to prosthesis wear, pain, and synovitis.Additionally, a contributing factor to the reported wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.However, this cannot be confirmed because the tibial insert was not returned for evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, h3, h6 - health effect - clinical code, medical device problem code, component code, type of investigation, investigation findings, investigation conclusion, h7, h9 and h11.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation.A definitive root cause was unable to be determined; however, may have been due to malalignment between the femoral and tibial components, fatigue wear, patient activity level, or any combination of these possibilities, which led to prosthesis wear, pain, and synovitis.Additionally, a contributing factor to the reported wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.However, this cannot be confirmed because the tibial insert was 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
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15777560
• Report Number: 1038671-2022-01451
• Device Sequence Number: 14734292
• Product Code: JWH
• UDI-Device Identifier: 10885862180773
• UDI-Public: 10885862180773
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/22/2026

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: 11/15/2019
• Device Model Number: LOGIC PS INSERT SZ 1.5, 13MM
• Device Catalogue Number: 02-012-35-1513
• 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: 10/21/2022
• Supplement Date Received by Manufacturer: 04/24/2023; 04/21/2026
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 05/18/2023; 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2011
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female