MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 3, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-47-3011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Emotional Changes (1831); Failure of Implant (1924); Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/06/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the legal, over a period of time, the patient's right knee began to suffer from symptoms associated with excessive wear of the exactech knee devices, including but not limited to pain and lack of mobility.As a direct and proximate result of the failure of the exactech devices, patient has been required to undergo surgical removal of the exactech devices, and now has components with decreased longevity.
Additional Manufacturer Narrative
Device evaluated by mfr: pending evaluation.Concomitant medical device(s): 5242937, 02-010-04-0330 - logic cr femoral por, right, sz 3; 4984788, 02-012-45-3020 - lgc tibial fit tray cem sz 3f / 2t; 4954612, 200-02-32 - three peg patella 32mm; 5269011, 201-78-15 - holding pin mini sharp point 4 pk; 4950786, 201-78-82 - collar fixation pin 2pk 40mm, quick release.
Additional Manufacturer Narrative
1038671-2024-04447 a2: added the following: date of birth.A3: added the following: gender.B1: corrected the following: type of report (check all that apply).B2: corrected the following: outcomes attributed to adverse event (check all that apply).D6b: added the following: if explanted, give date.G1: corrected the following: reporting contact first name, reporting contact last name, reporting contact facility name, reporting contact address line 1, reporting contact us city, reporting contact state (select from fda approved list), reporting contact us zip code(55555) or (55555-4444) or foreign postal, reporting contact country (select from fda approved list).H6: corrected the following: health effect - clinical code, component code, type of investigation, investigation findings, investigation conclusions.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and femoral loosening.The reported prosthesis wear and femoral loosening could not be confirmed.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: LOGIC CR TIB INSERT STD, SZ 3, 11MM
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16463668
• Report Number: 1038671-2023-00313
• Device Sequence Number: 6449594
• Product Code: JWH
• UDI-Device Identifier: 10885862174352
• UDI-Public: 10885862174352
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2024

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: 02/15/2026
• Device Catalogue Number: 02-012-47-3011
• 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: 02/09/2023
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2018
• 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: 55 YR
• Patient Sex: Female