MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; STEM, HUMERAL SIZE6 RSP

Catalog Number	506-00-006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	10/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Revision surgery - due to implants became loose over the years.Removed all original implants.
Additional Manufacturer Narrative
See h6, h10 and h11.Complaint has been evaluated and is similar to report number 1644408-2022-01038; 506-00-008, s810 - device loosening, revision surgery; surgical - quality complaints.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: DJO SURGICAL
• Common Device Name: STEM, HUMERAL SIZE6 RSP
• 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: 23444155
• Report Number: 1644408-2025-01612
• Device Sequence Number: 8533510
• Product Code: PHX
• UDI-Device Identifier: 00888912024372
• UDI-Public: 00888912024372
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K041066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2025

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 Catalogue Number: 506-00-006
• Device Lot Number: 205262
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 506-02-130 LOT: 993391; 506-03-114 LOT: 999161.; 506-03-118 LOT: 999201.; 506-03-122 LOT: 996791.; 506-04-032 LOT: 996231.; 506-32-003 LOT: 221242.; 506-32-104 LOT: 202882.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female