MAUDE Adverse Event Report: TOTAL JOINT ORTHOPEDICS, INC. KLASSIC SOMBRERO PATELLA WITH E-LINK; PATELLA IMPLANT

Catalog Number	5503.02.007
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient required revision surgery to correct a patella implant that the pegs sheared off after 2 years of use.Cement was bonded well to both bone and implant.Patient reported pain a few months ago, xrays showed nothing.She went back to the clinic on wednesday (b)(6) 2025 and it was clear the implant was off the bone and floating.The pegs were stuck and were removed with curettes and ronguer.
Additional Manufacturer Narrative
The most likely cause of this failure is a result of a fall that the patient had which resulted in the premature failure of the patella implant.There is no identified concern regarding the implant itself or the initial surgical implantation.

• Brand Name: KLASSIC SOMBRERO PATELLA WITH E-LINK
• Common Device Name: PATELLA IMPLANT
• Manufacturer (Section D): TOTAL JOINT ORTHOPEDICS, INC.; 1567 east stratford ave.; salt lake city UT 84106
• Manufacturer Contact: bobbi siddoway ; 1567 east stratford ave.; salt lake city, UT 84106 ; 8014866070
• MDR Report Key: 24003890
• Report Number: 3008544874-2026-00001
• Device Sequence Number: 21463441
• Product Code: JWH
• UDI-Device Identifier: 00814703014826
• UDI-Public: 00814703014826
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K180159
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 01/07/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 5503.02.007
• Device Lot Number: OPABD02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2023
• 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: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female