MAUDE Adverse Event Report: EXACTECH, INC. CEMENTED FINNED TIB. TRA SZ 3F/3T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-04-33
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Unspecified Tissue Injury (4559); Aseptic loosening (4883)
Date of Event	11/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 230-02-03 -optetrak asy, cr cemented femoral, sz 3: sn# (b)(6).200-04-33 - cemented finned tib.Tra sz 3f/3t: sn# (b)(6).200-02-35 - three peg patella 35mm: sn# (b)(6).H10: multiple mdr reports were filed for this event, please see associated report: 1038671-2022-01375.The revision reported may have been the result of polyethylene wear, osteolysis and tibial loosening.The aseptic (non-infected tibial loosening was likely the result of an insufficient bond between the tibial tray and the bone and/or patient-related conditions.However, this cannot be confirmed as the devices were not returned for evaluation.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The loosening may have led to an increase in cement and bone particles in the joint space and resulted in prosthesis wear or prosthesis wear may have contributed to particle-induced osteolysis.However, the contribution of loosening and prosthesis wear to the sequence of events cannot be determined as the devices were not available for evaluation and no images or radiographs were provided.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 that the patient underwent an initial total replacement on the left side.Subsequently, the patient experienced pain, discomfort, prosthesis wear, aseptic loosening and osteolysis.As a result, approximately seven years and eight months post-surgery, the patient underwent a revision.It was noted that "the patient had significant polyethylene wear on the tibial surface." moreover, surgeon indicated "there was gross osteolytic debris.The tibial baseplate was easily extracted and frankly loose.The femoral component, although well fixated, upon removal, there was a significant osteolytic non-contained cavitary defect that extended into the posterior condyle." no further impact to the patient was reported.No additional information is available.

• Brand Name: CEMENTED FINNED TIB. TRA SZ 3F/3T
• 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 court; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66 court; gainesville, FL 32653
• MDR Report Key: 24745518
• Report Number: 1038671-2026-00359
• Device Sequence Number: 8743618
• Product Code: JWH
• UDI-Device Identifier: 10885862039736
• UDI-Public: 10885862039736
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K932776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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: 01/05/2016
• Device Catalogue Number: 200-04-33
• 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: 10/13/2022
• Initial Report FDA Received Date: 03/31/2026
• Date Device Manufactured: 01/06/2011
• 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
• Patient Sex: Male