MAUDE Adverse Event Report: EXACTECH, INC. ONE PEG PATELLA 35MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-03-35
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Osteolysis (2377); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	05/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that a patient had a left total knee arthroplasty, and then experienced a revision surgical procedure approximately 6 years, 2 months after initial implant.Revision operative report postoperative diagnosis: aseptic loosening of left total knee arthroplasty and prosthetic wear.The patient was revised to competitor¿s devices.Inspection of the prosthetic knee components revealed significant polyethylene wear on the lateral facet of the patella component.The tibial polyethylene showed pronounced polyethylene wear in the lateral compartment.The patient was awakened and brought to the recovery room in stable condition.The devices were not returned, there are no images provided.There is no other information available.
Additional Manufacturer Narrative
1038671-2024-00428 report number " d10: 02-010-03-0240 - logic cr femoral cem, left, sz 4, 02-012-45-4050 - lgc tibial fit tray cem sz 4f / 5t, 02-012-47-4009 - logic cr tib insert std, sz 4, 9mm, 203-88-11 - (11-2954) ao/sodem 90x25x1.27 sawblade, 204-34-04 - fluted stem extension 40l x 14 mm, 204-70-00 - tibial stem ext.Screw.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-00428.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear 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.The product associated with the reported event is within the scope of recall z-2156-2024; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.".

• Brand Name: ONE PEG PATELLA 35MM
• 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
• MDR Report Key: 21376849
• Report Number: 1038671-2025-00903
• Device Sequence Number: 18280403
• Product Code: JWH
• UDI-Device Identifier: 10885862039668
• UDI-Public: 10885862039668
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/13/2025

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: 07/18/2021
• Device Catalogue Number: 200-03-35
• 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: 10/04/2023
• Initial Report FDA Received Date: 02/13/2025
• Date Device Manufactured: 07/19/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male