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

Catalog Number	200-02-35
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Osteolysis (2377); Joint effusion (4849)
Date of Event	04/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial total knee arthroplasty on the right side.Subsequently, the patient experienced pain, discomfort, polyethylene wear, bone loss, osteolysis and component loosening.As a result, approximately nine years and six months post-surgery, the patient underwent a revision.It was noted that there was significant reactive tissue about both the femoral and tibial components, they were grossly loose, there was gross fracture of the polyethylene.The patellar button had minimal abrasive wear.There was a lot of osteolytic debris present throughout the knee.Patient was last known to be in stable condition following the event.No further impact to the patient was reported.No additional information is available.This is report 2 of 4 for this event/patient.
Additional Manufacturer Narrative
D10: 02-010-03-0330 - logic cr femoral cem, right, sz 3: sn# (b)(6).02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t: sn# (b)(6).02-012-48-3011 - logic cr tib insert slope+, sz 3, 11mm: sn# (b)(6).201-78-14 - holding pin headless sharp point long 4pk: sn# (b)(6).201-78-15 - holding pin mini sharp point 4 pk: sn# (b)(6).203-96-42 - 11-4132 stryker sys 6 90x13/21x1.19: sn# (b)(6).200-00-00 - knee item-misc.H10: multiple mdr reports were filed for this event, please see associated report: 1038671-2022-01516.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.A definitive root cause was unable to be determined; however, may been the result of prosthesis wear, osteolysis, and insufficient bonds between the devices and the bones, which led to aseptic (non-infected) loosening.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: THREE 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: ashley harris ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 24927037
• Report Number: 1038671-2026-00458
• Device Sequence Number: 12116918
• Product Code: JWH
• UDI-Device Identifier: 10885862039606
• UDI-Public: 10885862039606
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• 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): 04/20/2026

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: 10/14/2017
• Device Catalogue Number: 200-02-35
• 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: 11/08/2022
• Initial Report FDA Received Date: 04/20/2026
• Date Device Manufactured: 10/17/2012
• 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: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 91 KG