MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; INSERT, 3D EX SZ 4LT 9MM

Catalog Number	391-09-704
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The agent reported revision for infection.Complaint has been evaluated and is similar to report number 1644408-2019-00823; 391-09-704, s808 - infection, 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
Revision surgery due to grossly infected requiring removal of components & placement of spacer.Female 71.

• Brand Name: DJO SURGICAL
• Common Device Name: INSERT, 3D EX SZ 4LT 9MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: stacey bonnell ; 9800 metric blvd.; austin, TX 78758
• MDR Report Key: 25553166
• Report Number: 1644408-2026-01193
• Device Sequence Number: 18831933
• Product Code: OIY
• UDI-Device Identifier: 00888912118941
• UDI-Public: 00888912118941
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K091956
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 06/18/2026

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 Expiration Date: 09/22/2025
• Device Catalogue Number: 391-09-704
• Device Lot Number: 281G1965
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/29/2020
• 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: 130-03-732 LOT: 155N2730.; 233-01-104 LOT: 885A1354.; 333-01-104 LOT: 270B1214.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female