MAUDE Adverse Event Report: EXACTECH, INC. KNEE FEMORAL COMPONENT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-01-0220
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Osteolysis (2377); Ambulation or Postural Difficulties (2544)
Date of Event	07/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that approximately 156 months after a left total knee replacement procedure, the patient was experiencing pain and difficulty ambulating.History, physical examination, and imaging suggested aseptic loosening due to defective polyethylene.The patient wished to proceed with a revision.A synovectomy was performed.The patella was dislocated laterally.The patella was found to be well fixed.The patella was removed.The polyethylene was removed.Attention was then turned to the femur.The femoral component was well fixed.The femur was removed and cement was removed from the distal femur and canal.Bony inventory after removed of the femoral component revealed aori type 1 bone loss due to osteolysis.Attention was then turned to the tibia.The tibial component was fond to be well fixed.The tibial component was removed.The remainder of the cement was removed.Boney inventory revealed aori type 1 bone loss due to osteolysis.Most of the bone loss was central-lateral and anteriorly involving the anterior cortex.Cement restrictors were placed in the femur and tibia.Cement was mixed.The tibia and femur were irrigated and the canals were dried.Cement was first placed over the areas of bone graft so these would not displace upon insertion of the components.The final femoral component was cemented, followed by the final patella button and final tibia component.The final polyethylene was impacted.Excess cement was removed.Once the cement hardened the knee was taken through range of motion and fond to have excellent stability and patellar tracking.The patient was transferred to the recovery room in stable condition.Additional information received indicates the patient has suffered from pain, stiffness, discomfort, and weakness due to polyethylene wear, which in turn negatively affected the patient's mobility and quality of life and necessitated a revision surgery.The patient endured pain following surgery and during the rehabilitation period which required physical therapy.The patient's ability to perform normal physical activities has been consequently limited.Additional information received from the hospital indicates the patient was revised due to femoral knee debonding/loosening; mechanical loosening of internal left knee prosthetic joint.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: g.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h6, h11.The following sections were corrected: d1, d4, g4, h4.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.Medical records were provided for review.The review identified no abnormalities in usage or surgical technique performed.A review of complaint history determined that no further action is required as no trends were identified.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and femoral loosening or due to inclusion of the polyethylene in the packaging recall.Based on the reported information, it appears that the ambulation difficulties, osteolysis, and synovitis may be related to the reported loosening and wear.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.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: KNEE FEMORAL COMPONENT
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 23546730
• Report Number: 1038671-2025-03331
• Device Sequence Number: 9775617
• Product Code: JWH
• UDI-Device Identifier: 10885862001122
• UDI-Public: 10885862001122
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/18/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/28/2016
• Device Catalogue Number: 02-010-01-0220
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 02/12/2026; 03/05/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 02/12/2026; 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2011
• 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: 74 YR
• Patient Sex: Female