MAUDE Adverse Event Report: EXACTECH, INC. LOGIC KNEE COMPONENTS; LOGIC CR FEMORAL POR, RIGHT, SZ 3.5

Catalog Number	02-010-04-0335
Health Effect - Clinical Codes	No Information (3190); Joint Laxity (4526); Muscle/Tendon Damage (4532)
Date of Event	09/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Revised due to instability ¿ ruptured posterior cruciate ligament (pcl), revised to hinge.The patient was stable as they left the operating room.There was no delay to the surgery.The rep was present at the time of the surgery.
Additional Manufacturer Narrative
Section h10: (h3) the clinical evaluation noted the device was used for treatment, not diagnosis.There is no indication that there is a device related problem, there is no allegation against the device.The most likely cause of the reported event, instability/subluxation, is related to the underlying patient condition of ruptured posterior cruciate ligament (pcl).(d11) concomitant devices: - tibial inserts cr cn; 02-012-47-3509 / sn; (b)(6) - fit tibial tray (cn: 02-012-45-3525 / sn: (b)(6).- three peg patella, 32mm cn: 200-02-32 / sn: (b)(6).No information provided in the following section(s): a2, a3, a4, a5, b6, and b7.The following section(s) have additional info: b5, g4, g7, h1, h2, h3, and h7.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: h6 the following sections were corrected: b5 - please disregard product information, no informaiton available.
Event or Problem Description
It was reported that this patient's left knee was revised due to instability.Patient had a ruptured posterior cruciate ligament (pcl), revised to hinge.The patient suffers from right knee aggravation.The knee and lumbar spine aggravation are consequential to the right knee with ongoing impairment.The patient was stable as they left the operating room.There was no delay to the surgery.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h6, h11.H11: 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 complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, it may be due to a traumatic event/injury, soft tissue imbalance, patient anatomy, implant positioning, and/or implant selection.However, the failure could not be confirmed because the devices were not returned for evaluation, and relevant patient information, images, or 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 KNEE COMPONENTS
• Common Device Name: LOGIC CR FEMORAL POR, RIGHT, SZ 3.5
• 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: kate jacobson ; 3523782617
• MDR Report Key: 9163187
• Report Number: 1038671-2019-00494
• Device Sequence Number: 16837828
• Product Code: JWH
• UDI-Device Identifier: 10885862158383
• UDI-Public: 10885862158383
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123687
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/12/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/14/2020
• Device Catalogue Number: 02-010-04-0335
• 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: 09/13/2019
• Supplement Date Received by Manufacturer: 10/17/2019; 12/03/2024; 01/23/2026
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 11/05/2019; 12/19/2024; 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2015
• 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: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown