MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; GLENOID, HEAD W/RETAINING SCREW, RSP, 32MM/-4MM

Catalog Number	508-32-103
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	06/18/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to report number 1644408-2020-01178; 508-36-101, 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
Revision surgery - due to loosening.

• Brand Name: DJO SURGICAL
• Common Device Name: GLENOID, HEAD W/RETAINING SCREW, RSP, 32MM/-4MM
• 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: 25755513
• Report Number: 1644408-2026-01316
• Device Sequence Number: 10413352
• Product Code: PHX
• UDI-Device Identifier: 00888912024747
• UDI-Public: 00888912024747
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K051075
• 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): 07/08/2026

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: Lay User/Patient
• Device Catalogue Number: 508-32-103
• Device Lot Number: 864C7753
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2025
• 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: 506-04-114 LOT: 5031A1080; 506-04-114 LOT: 5031A1080; 506-04-118 LOT: 5033A1019; 506-04-126 LOT: 5037A1020; 508-32-204 LOT: 769P3933; 509-02-032 LOT: 951W2974; 533-08-000 LOT: 004Y1435
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female