MAUDE Adverse Event Report: EXACTECH, INC. TRAP TRAY, OFFSET ALPHA CEM., SZ 4F/4T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	SPECIFIC DEVICE NOT REPORTED
Medical Device Problem Codes	Mechanical Problem (1384); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Implant Pain (4561); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Aseptic loosening (4883)
Date of Event	06/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
As reported via legal documentation the male patient had a right knee replacement on (b)(6) 2009.Approximately 13 years and 7 months after the initial procedure the patient had a right knee revision on (b)(6) 2023.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.Revision op report on (b)(6) 2023; diagnosis: failed right knee arthroplasty secondary to tibial loosening and massive osteolysis.Findings consistent with polyethylene-induced synovitis.A synovectomy was performed.It was clear that the tibia had failed into varus with significant medial bone loss.There was delamination of the tibial polyethylene.There was an area of massive osteolysis under the anterior trochlea that had already been appreciated by the ct scan.There was also significant osteolysis of the medial femoral condyle.The patient was transferred to the pacu in stable condition without complication.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d6a, h6 mdr section codes updated/corrected: a, b, c, d, e, g the reason for the revision reported cannot be confirmed from the information provided but may be the result of tibial loosening, loss of range of motion, subsidence/migration, and prosthesis wear.Or due to inclusion of the polyethylene in the packaging recall.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.Potential contributions of manufacturing, user, and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and product information were not 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 a right total knee arthroplasty.Subsequently, it was reported that the patient experienced pain, swelling, stiffness, loss of motion, weakness and difficulty ambulating.As a result, the patient underwent a right knee revision approximately 13 years and 7 months after initial implantation.Provided operative notes report tibial loosening and wear of the tibial insert.It was later reported that the femoral component was found to be debonded.The patient was last reported to be stable.No further patient impact reported.No further information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b5.The following sections were corrected: b1, d1, d4, d6a, e1, g4, h4.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were added/corrected: h6: clinical code.The reason for the revision reported cannot be confirmed from the information provided but may be the result of tibial loosening, loss of range of motion, 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 pain, swelling, osteolysis, synovitis, 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: TRAP TRAY, OFFSET ALPHA CEM., SZ 4F/4T
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• 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: kate jacobson ; 3523771140
• MDR Report Key: 17423128
• Report Number: 1038671-2023-01811
• Device Sequence Number: 12676935
• Product Code: JWH
• UDI-Device Identifier: 10885862053411
• UDI-Public: 10885862053411
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K023186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/10/2026

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: 10/16/2013
• Device Model Number: SPECIFIC DEVICE NOT REPORTED
• Device Catalogue Number: 208-04-43
• 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: 06/29/2023
• Supplement Date Received by Manufacturer: 06/10/2025; Not provided; 02/09/2026
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 06/11/2025; 11/17/2025; 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2008
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male