MAUDE Adverse Event Report: EXACTECH, INC. THREE PEG PATELLA 41MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-02-41
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	04/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation approximately 89 months after a patient had a right total knee arthroplasty, the patient underwent a right total knee revision procedure, the patient experienced pain and mobility issues.Operative photos/x-rays were provided.Intraoperatively, the surgeon observed significant wear on both the tibial insert and patella polyethylene components.There were no medical or surgical interventions reported.Patient was last known to be in stable condition following the event.No additional information is available.Concomitants products: complaint investigation findings: the revision reported was likely the result of instability, axial rotational mismatch between the femoral and tibial components, third body wear, and/or patient-related conditions, which resulted in polyethylene wear, delamination, and pain.However, this cannot be confirmed as the devices were not returned for evaluation.The most probable root cause associated with the reported event of "prosthesis wear¿ is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.510k: k033883 fda recall z-0021-2022.
Additional Manufacturer Narrative
D10: logic femoral ps cem right sz 5 (cat# 02-010-01-0350 / serial# (b)(6), lgc tibial fit tray cem sz 5f / 6t (cat# 02-012-45-5060 / serial# (b)(6), tibial stem ext.Screw (cat# 204-70-00 / serial# (b)(6), fluted stem extension 40l x 14 mm (cat# 204-34-04 / serial# (b)(6).The product associated with the reported event is within the scope of recall 1038671-2022-00538; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.Multiple mdr reports were filed for this event, please see associated report: 1038671-2022-00538.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: b, c, d, e.The revision reported was likely the result of instability, axial rotational mismatch between the femoral and tibial components, third body wear, and/or patient-related conditions, which resulted in polyethylene wear, delamination, and pain.However, this cannot be confirmed as the devices were not returned for evaluation.The most probable root cause associated with the reported event of "prosthesis wear¿ is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.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 41MM
• 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: 21889773
• Report Number: 1038671-2025-01875
• Device Sequence Number: 18186254
• Product Code: JWH
• UDI-Device Identifier: 10885862039620
• UDI-Public: 10885862039620
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 06/17/2025

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: 03/19/2019
• Device Catalogue Number: 200-02-41
• 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: 10/13/2023
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 06/17/2025
• Date Device Manufactured: 03/20/2014
• 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: 63 YR
• Patient Sex: Male