MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; SHELL, BIPOLAR, MODULAR, ENCORE, SIZE46

Catalog Number	412-02-046
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/25/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The agent reported patient had dislocated post-operatively.Complaint has been evaluated and is similar to report number 1644408-2021-01061; 412-02-048, s803 - dislocation, 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 patient had dislocated post-operatively.

• Brand Name: DJO SURGICAL
• Common Device Name: SHELL, BIPOLAR, MODULAR, ENCORE, SIZE46
• 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 ; 5128346313
• MDR Report Key: 24891967
• Report Number: 1644408-2026-00727
• Device Sequence Number: 8921100
• Product Code: KWY
• UDI-Device Identifier: 00888912077378
• UDI-Public: 00888912077378
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K953510
• 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): 04/15/2026

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: 412-02-046
• Device Lot Number: 991B1278A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2025
• 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: 400-03-281 LOT: 857B1399
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female