MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 2, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Catalog Number	02-012-44-2013
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Swelling/ Edema (4577); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via a legal filing that a female patient who had an initial right knee implant procedure on (b)(6) 2013, claimed she sustained injuries resulting from her knee prosthesis, and was revised approximately 8 years and 8 months post her initial procedure.No further information known.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the subsequent revision for cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.
Additional Manufacturer Narrative
No device return anticipated due to this being a legal case.
Additional Manufacturer Narrative
Additional information- a2, b1, b5, b6, d4 all, d10, e3, g4 510k, h4, h6.Type of investigation, investigation findings, investigation conclusions, h7, & h9.D10.Concomitants: optetrak logic femoral component (02-010-01-0320, 2811278).Optetrak logic tibial tray (02-012-41-2010, 2487165).Exactech patella 3 peg (200-02-32, 2776640).H6.Investigation results-the revision reported may have been the result of malalignment between the femoral and tibial components, third body wear, patient-related conditions, instability, or any combination of these possibilities, which led to wear of the polyethylene insert.However, this cannot be confirmed as the device was not returned for evaluation and images of the explanted device and pre-revision radiographs were not provided.These devices are for treatment not diagnosis.There is no other information available.
Event or Problem Description
Additional information-revision operative report of (b)(6) 2022-postoperative diagnosis: failed right total knee replacement secondary to wear of the bearing surface.Patient came to physician due to increasing swelling.Exam suggested hypertrophic synovitis with large synovial effusion.Synovial fluid was aspirated and showed white blood cell count was low with predominantly lymphocytes and monocytes.During surgery, exuberant synovitis with significant synovial lining hypertrophy.Tibial polyethylene insert was removed and inspected and there was moderate wear of both the medial and lateral articular surfaces.No complications.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, d1, e1, e2, e3, h3, h6 - health effect - clinical code, medical device problem code, component code, type of investigation, h7 and 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.A definitive root cause was unable to be determined; however, may have resulted from malalignment between the femoral and tibial components, third body wear, patient-related conditions, instability, or any combination of these possibilities, which led to wear of the polyethylene insert.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 IMPLANT PSC INSERT, SZ 2, 13MM
• 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: 15346924
• Report Number: 1038671-2022-01010
• Device Sequence Number: 14711843
• Product Code: JWH
• UDI-Device Identifier: 10885862173492
• UDI-Public: 10885862173492
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 04/14/2026

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: 09/25/2021
• Device Catalogue Number: 02-012-44-2013
• 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: 08/01/2022
• Supplement Date Received by Manufacturer: 08/04/2023; 04/09/2026
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 08/08/2023; 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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.; UNK.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female