MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CC TIB INSERT SIZE 4, 17MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC CC FEMORAL SIZE 4, RIGHT
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Aseptic loosening (4883)
Date of Event	10/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant products: logic cc tib insert size 4, 17mm (cat# 02-012-65-4017 / serial# (b)(4), logic stem ext 18mm x 80mm (cat# 02-012-60-1880 / serial# (b)(4), three peg patella 38mm (cat# 200-02-38 / serial# (b)(4), 3" trocar, mod.Hex 2pk (cat# 201-78-81 / serial# (b)(4), threaded pin size 2.3 collared 2pk (cat# 521-78-23 / serial# (b)(4).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported by the legal brief, on (b)(6) 2020, patient underwent revision of his failed right optetrak device.During the revision procedure, patient¿s surgeon noted defective equipment requiring complete revision.Subsequently, patient underwent a second revision surgery due to defective equipment on (b)(6) 2022.Upon information and belief, the defective optetrak device failed prematurely in patient¿s right knee.The polyethylene component used in the optetrak device was defective, leading to early aseptic loosening.A packaging defect in the packaging containing the optetrak polyethylene inserts accelerated polyethylene wear due to oxidation.
Additional Manufacturer Narrative
As a result of the investigation, the product in question and failure mode have been altered, as such, the following fields have been updated: d1, d4, d10, g4, h4, and h6.D10.Concomitants: 02-010-06-0340 - logic cc femoral size 4, right, 6261302, 02-012-60-1880 - logic stem ext 18mm x 80mm, 5833757, 200-02-38 - three peg patella 38mm, 5586944, 201-78-81 - 3" trocar, mod.Hex 2pk, 6167756.H6: investigation results - the reason for the revision cannot be confirmed from the information provided, but may be due to prosthesis wear as reported, patient conditions, use of incompatible sized components or inclusion of the polyethylene in the packaging recall.However, the reported prosthesis wear could not be confirmed as no images or radiographs were provided and the devices were not available for evaluation.
Event or Problem Description
Report #1 of 2 for this event.As reported via legal documentation a patient underwent a revision of the right knee total arthroplasty.Subsequently, two (2) years later, the patient underwent a second (2nd) right knee revision due to pain, prosthesis wear and aseptic (non-infected) loosening.The tibial insert component was exchanged.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b5, e (correcting initial report), g2 (correcting initial report),h6: clinical codes, component code, types of investigation.H10: multiple mdr reports were filed for this event, please see associated report: 1038671-2026-00236.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 TIB INSERT SIZE 4, 17MM
• 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 ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16092560
• Report Number: 1038671-2023-00004
• Device Sequence Number: 12414785
• Product Code: JWH
• UDI-Device Identifier: 10885862266149
• UDI-Public: 10885862266149
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2026

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 Model Number: LOGIC CC FEMORAL SIZE 4, RIGHT
• Device Catalogue Number: 02-012-65-4017
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2022
• Supplement Date Received by Manufacturer: 09/18/2023; 02/25/2026
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 09/21/2023; 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2020
• 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 H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male