MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CC FEMORAL SIZE 2, LEFT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	N/A
Medical Device Problem Codes	Mechanical Problem (1384); Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Osteolysis (2377); Fibrosis (3167); Joint Laxity (4526); Implant Pain (4561)
Date of Event	01/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately nine years post initial left tka, the surgeon revised a logic cc 0f the 56 y/o female patient due to loosening of the femoral construct.The patient was revised with logic cc.There was no breakage of devices or surgical delay/prolongation.Patient was last known to be in stable condition following the event image received.Sales rep was unable to obtain x-rays.The devices are not available for evaluation due to devices are kept by legal.
Additional Manufacturer Narrative
Section d10: concomitant products.Tru post.Aug.Size 2, 5mm (cat# 02-010-06-0521 / serial# (b)(6).Lgc tibial fit tray cem sz 2f / 2t (cat# 02-012-45-2020 / serial# (b)(6).Tru tib aug 1/2 size 2, 5mm (cat# 02-012-50-2011 / serial# (b)(6).Tru stem ext 10mm x 80mm (cat# 02-012-60-1080 / serial# (b)(6).Tru cc tib insert size 2, 15mm (cat# 02-012-65-2015 / serial# (b)(6) - recall z-0021-2022).Three peg patella 35mm (cat# 200-02-35 / serial# (b)(6).Small headed sharp pin, 1 1/8" 4 pack (cat# 201-78-25 / serial# (b)(6).Cc distal fem augment sz 2, 10mm (cat# 208-06-02 / serial# (b)(6).Threaded pin size 2.6 collarless 2pk (cat# 521-78-31 / serial# (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: d8 g1 h6 the following sections were corrected: b2 b5 d4: model number h6 the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
As reported, approximately nine years post initial left tka, the surgeon revised a logic cc of the patient due to loosening of the femoral construct.The patient experienced pain, osteolysis and fibrosis.They were revised with logic cc.There was no breakage of devices or surgical delay/prolongation.Patient was last known to be in stable condition following the event image received.Sales rep was unable to obtain x-rays.The devices are not available for evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of femoral loosening, instability, loss of range of motion, subsidence/migration, and prosthesis wear.Or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images 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 CC FEMORAL SIZE 2, LEFT
• 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: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 18813022
• Report Number: 1038671-2024-00360
• Device Sequence Number: 4289576
• Product Code: JWH
• UDI-Device Identifier: 10885862265654
• UDI-Public: 10885862265654
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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,Followup
• Report Date (Section B): 06/16/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/12/2020
• Device Model Number: N/A
• Device Catalogue Number: 02-010-06-0220
• 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: Not provided
• Supplement Date Received by Manufacturer: 03/17/2025; 06/13/2025
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 03/18/2025; 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2015
• 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: STRYKER 2000 90X13/21X 1.9MM.; THREADED PIN SIZE 2.6 COLLARLESS 2PK.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 49 KG