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	Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	09/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 1.5 years post op the initial right total knee arthroplasty, this patient was revised due to a swollen knee and pain due to polyethylene wear.The insert and patella components were revised.The patient was last known to be in stable condition following the event.No further patient impact was reported.No additional information is available.
Additional Manufacturer Narrative
D10: 02-012-51-4011 - logic tib insert impl crc, sz 4, 11mm, 02-010-04-0340 - logic cr femoral por, right, sz 4 (b)(6), 02-012-45-4050 - lgc tibial fit tray cem sz 4f / 5t (b)(6), g2: australia.H10: multiple mdr reports were filed for this event, please see associated report: 1038671-2022-01234.The revision reported in this event was most likely the result of prosthesis wear initiated by unintended contact between incongruent surfaces of the tibial insert and femoral component.However, contributions from instability of the knee joint, component alignment, and/or patient-conditions to the sequence of events cannot be determined from the reported clinical information.The returned patella appears to have localized damage.The remainder of the articular surface appears to have minimal indications of damage.One of the pegs appears to have been sheared off -most likely during the explantation process.If the femoral component was in flexion, the apical damage pattern of the patella may have occurred secondary to articular contact against the flatter anterior portion of the femur rather than articulating within the trochlear groove as intended.However, this cannot be confirmed from the provided information.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: 23926214
• Report Number: 1038671-2025-03649
• Device Sequence Number: 9152612
• Product Code: JWH
• UDI-Device Identifier: 10885862039620
• UDI-Public: 10885862039620
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/30/2025

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: 07/05/2021
• Device Catalogue Number: 200-02-41
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2016
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female