MAUDE Adverse Event Report: EXACTECH, INC. CEMENTED CR FEMORAL; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	FEMORAL COMPONENTS
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Balance Problems (4401)
Date of Event	05/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately four years post left tka, this female patient underwent revision due to aseptic loosening.No additional information is available or forthcoming.The device is not available for evaluation.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of an insufficient bond between the implant and the bone and patient-related conditions, which led to aseptic (noninfected) loosening.However, this cannot be confirmed as the devices were not available for evaluation and pre-revision x-rays were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Corrected fields: d1, h6 clinical codes, h6 component code additional information fields: a2, b2, b5, b7, d4, d10, g, g2, g3, h6 investigation codes.D10: (b)(6), 208-23-18 - cc tibial insert sz 3, 18mm, (b)(6), 204-36-16 - stem extension w/slot 160l x16 mm, (b)(6), 208-06-03 - cc distal fem augment sz 3, 10mm, (b)(6), 208-09-05 - cc stem ext adaptor 5 degree.
Event or Problem Description
It was reported via legal documentation that approximately 48 months after a left total knee revision procedure, the patient underwent a second revision procedure to address a loose and migrated femoral component.Initial surgery and revision surgery operative notes were provided.Post operative diagnosis noted: failure of total knee replacement, initial encounter.Intraoperatively it was noted that there was no evidence of gross infection or purulence.It was noted the allograft patellar tendon appeared to be well healed to the bone and incorporated into the tissue; therefore, was left alone.It was noted that polyethylene insert was noted to be removed without issue.The patella was noted to be well fixed.No medical or surgical interventions were reported.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h6: medical device problem code and investigation codes.H10: multiple mdr reports were filed for this event, please see associated reports: 1038671-2025-01670 and 1038671-2025-01747.H11: the reason for the revision reported in this event cannot be confirmed from the information provided but may be the result of femoral loosening, instability, prosthesis wear, and femoral stem loosening.Or due to inclusion of the polyethylene in the packaging recall.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.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: CEMENTED CR FEMORAL
• 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: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 13390045
• Report Number: 1038671-2022-00082
• Device Sequence Number: 4999553
• Product Code: JWH
• UDI-Device Identifier: 10885862053220
• UDI-Public: 10885862053220
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/23/2025

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: 02/21/2021
• Device Model Number: FEMORAL COMPONENTS
• Device Catalogue Number: 208-01-03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2022
• Supplement Date Received by Manufacturer: 06/10/2022; 11/09/2023; 06/20/2025
• Initial Report FDA Received Date: 01/29/2022
• Supplement Report FDA Received Date: 07/05/2022; 03/26/2025; 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2016
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female