MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 3.5, 9 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	LOGIC CR TIB INSERT STD, SZ 3.5, 9 MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 2822789, 02-010-03-0335, logic cr femoral cem, right, sz 3.5; 5404146, 02-012-45-3535, lgc tibial fit tray cem sz 3.5f / 3.5t; 6038382, 200-02-41, three peg patella 41mm; 5279765, 201-78-15, holding pin mini sharp point 4 pk; 5284137, 201-78-81, 3 trocar, mod.Hex 2pk; 5284161, 201-78-81, 3 trocar, mod.Hex 2pk; 5284175, 201-78-81, 3 trocar, mod.Hex 2pk; 323871, 203-96-40, (11-3661) stryker sys 6 90x25x1.27; 332364, 203-96-42, (11-3671) stryker sys 6 90x13/21x1.19; s018337, 521-78-23, threaded pin size 2.3 collared; s018357, 521-78-23, threaded pin size 2.3 collared; s010942 521-78-36, threaded pin size 5.1 collarless.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a 64 yo female patient, initial right knee implanted on (b)(6) 2019, underwent a revision procedure on (b)(6) 2022, approximately 3 years 1 month post the initial procedure due to poly wear.The patient last known to be in stable condition.No other patient/medical information reported.The product is not returning as it was disposed of by the hospital.No further information.
Additional Manufacturer Narrative
H6: the revision reported may have been the result of malalignment between the femoral and tibial components, third body wear, instability, patient-related conditions, or any combination of these possibilities, which led to wear of the polyethylene component.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 as the device was not returned for evaluation and images/x-rays were unable to be obtained.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, d1, h6 - health effect - clinical code, component code, type of investigation, h7 (remove erroneous entry from initial report), h9 (remove erroneous entry from initial report) 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 the result of malalignment between the femoral and tibial components, third body wear, instability, patient-related conditions, or any combination of these possibilities, which led to wear of the polyethylene component.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.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC CR TIB INSERT STD, SZ 3.5, 9 MM
• 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: 15790147
• Report Number: 1038671-2022-01460
• Device Sequence Number: 5501193
• Product Code: JWH
• UDI-Device Identifier: 10885862159243
• UDI-Public: 10885862159243
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2026

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: 03/25/2022
• Device Model Number: LOGIC CR TIB INSERT STD, SZ 3.5, 9 MM
• Device Catalogue Number: 02-012-47-3509
• 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: 10/31/2022
• Supplement Date Received by Manufacturer: 02/14/2023; 04/22/2026
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 03/08/2023; 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2014
• 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 Age: 64 YR
• Patient Sex: Female