MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 1, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	02-012-47-1009
Medical Device Problem Codes	Fracture (1260); Unstable (1667); Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Erosion (1750); Failure of Implant (1924); Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544); Balance Problems (4401); Joint Laxity (4526); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
Date of Event	07/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 4 years post op the initial left tka, this 77 y/o female patient had a poly exchange, old implant removed, new implant implanted.No breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Device is not returning, hospital would not release implant.
Additional Manufacturer Narrative
Device evaluated by manufacturer: pending evaluation.Concomitant device(s): 02-010-03-0210, logic cr femoral cem, left sz 1, sn: (b)(4).02-012-45-1010, lgc tibial fit tray cem sz 1f / 1t, sn: (b)(4).200-02-29, three peg patella 29mm, sn: (b)(4).
Event or Problem Description
As reported, approximately 4 years post op the initial left tka, this 77 y/o female patient had a poly exchange, old implant removed, new implant implanted.Patient was revised to exactech implants.No breakage of device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.Device is not returning, hospital would not release implant.New information 13 oct 22: representative stated revision dur to poly recall.No additional information.
Additional Manufacturer Narrative
Section h10: (h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent poly swap/revision has been reported to be due to the device recall; no other reason reported.Section h11: *the following sections have corrected information: (b5) describe event or problem: as reported, approximately 4 years post op the initial left tka, this 77 y/o female patient had a poly exchange, old implant removed, new implant implanted.Patient was revised to exactech implants.No breakage of device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.Device is not returning, hospital would not release implant.New information 13 oct 22: representative stated revision dur to poly recall.No additional information.
Additional Manufacturer Narrative
Section h11: *the following sections have corrected information: (h3) the revision reported was likely the result of prosthesis wear.Contributing factors to the severity of the wear on the tibial insert may have been result of being packaged in a non-conforming vacuum bag for more than five years.However, this cannot be confirmed as the devices were not available for evaluation.(h6) component code: 734, bearings; type of investigation: 4114, device not returned, 4109, historical data analysis; investigation findings: 4243, packaging materials problem, 140, wear problem; investigation conclusions: 22, known inherent risk of device.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b5, d8, g2 (correcting initial report), h6: clinical codes, medical device problem codes, component code, types of investigation and investigation findings.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported a patient underwent an initial total knee arthroplasty.Subsequently, 3 years, 9 months later, the patient underwent a left knee revision of the tibial insert due to polyethylene wear.It was reported via legal documentation the insert was discolored, fractured with pitting and delamination.Additionally, it was reported via legal documentation, the patient continues to experience pain, discomfort, ambulatory difficulties, balance issues, component part loosening tissue and bone loss.No additional information is available.

• Brand Name: LOGIC CR TIB INSERT STD, SZ 1, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15381005
• Report Number: 1038671-2022-01060
• Device Sequence Number: 12211690
• Product Code: JWH
• UDI-Device Identifier: 10885862174130
• UDI-Public: 10885862174130
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/07/2026

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: 08/01/2019
• Device Model Number: 02-012-47-1009
• Device Catalogue Number: 02-012-47-1009
• 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: 08/18/2022
• Supplement Date Received by Manufacturer: 10/17/2022; 06/19/2023; 01/23/2026; 07/02/2026
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 11/08/2022; 06/30/2023; 02/05/2026; 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Female