MAUDE Adverse Event Report: ENCORE MEDICAL LP DJO SURGICAL; DOMED TRI-PEG PATELLA, 29X8MM, E-PLUS

Model Number	130-03-729
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to report number cc-00365649_1644408-2022-00401; 130-03-732, s809 - trauma, s810 - device loosening, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.
Event or Problem Description
The patient experienced a fall in which their press-fit patella implant became medially dislodged.Purpose of follow up operation was to remove that implant and replace with a cemented patella.

• Brand Name: DJO SURGICAL
• Common Device Name: DOMED TRI-PEG PATELLA, 29X8MM, E-PLUS
• Manufacturer (Section D): ENCORE MEDICAL LP; 9800 metric blvd.; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL LP; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: stacey bonnell ; 9800 metric blvd.; austin, TX 78758 ; 8003219549
• MDR Report Key: 25462925
• Report Number: 1644408-2026-01139
• Device Sequence Number: 21383757
• Product Code: JWH
• UDI-Device Identifier: 00888912108522
• UDI-Public: 00888912108522
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2026

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 Model Number: 130-03-729
• Device Lot Number: 154N2090
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2026
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 91 KG