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 Codes	Patient-Device Incompatibility (2682); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Exostosis (bone) (4891)
Date of Event	08/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that approximately 15 months after a left total knee replacement procedure, the patient underwent a procedure to address lateral patellar sided pain.He did well early post operatively and then developed pain, which did not improve over the course of the year.Surgical workup at one-year post-op revealed some tilt to the lateral patella with a small fleck of bone medially.Revision surgery operative notes were provided.Intraoperative findings indicated abundant osseous overgrowth along the lateral side of the patella.The surgeon performed a left knee debridement of the lateral patella bone and a lateral retinacular release.At the completion of the procedure the patellar was tracking well with no bony impingement on the femoral component relative to the patella.The patient was transferred to the pacu in stable condition.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d1, d2a, d2b, d4 d10: 5382452 - 02-020-11-0250 - truliant ps cem fem ps cem left sz 5 s100241 - 02-022-35-5009 - truliant tib imp ps insert sz 5 9mm 5381879 - 02-022-45-5050 - truliant tib fit tray cem sz 5f / 5t g4, h4, h6 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.Medical records were provided for review.The review identified no user-related issues reported that appear to have contributed to the reported event.It was reported in the operative note that scar and fibrotic tissue was present laterally and inferiorly around the patella and that there was boney overgrowth on the lateral side of the patella.No manufacturing process-related non-conformances, deviations, or exceptions are associated with the manufacturing lot of 30 patellar components.A review of complaint history determined that no further action is required as no trends were identified.The patellar tracking issue reported appears to be the result of patient-related issues secondary to scar tissue and boney overgrowth as reported.However, this cannot be confirmed and contributing factors from patient or user-related issues cannot be determined because the devices were not available for evaluation as they remain implanted, and images or radiographs were not provided.Patella tracking may be secondary to a combination of issues including implant alignment, insufficient patellar resection, and/or soft-tissue imbalances.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 corrected information.The following sections were corrected: d10: (b)(6) - 02-020-11-0250 - truliant ps cem fem ps cem left sz 5.(b)(6) - 02-022-35-5009 - truliant tib imp ps insert sz 5 9mm.(b)(6) - 02-022-45-5050 - truliant tib fit tray cem sz 5f / 5t.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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20820627
• Report Number: 1038671-2024-04555
• Device Sequence Number: 15664378
• Product Code: JWH
• UDI-Device Identifier: 10885862039620
• UDI-Public: 10885862039620
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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,Followup
• Report Date (Section B): 09/10/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/10/2022
• 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: 11/19/2024
• Supplement Date Received by Manufacturer: 09/09/2025; 09/10/2025
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 09/10/2025; 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2017
• 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: 62 YR
• Patient Sex: Male