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

Catalog Number	508-32-101
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	05/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The agent reported revision surgery do to the gleosphere came off the baseplate.Dr.Put the glenosphere back on with a new retaining screw and a new insert.58 years/294 lb/male.Complaint has been evaluated and is similar to report number 1644408-2021-00080; 508-36-101, s817 - dissociation, 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 the glenoshpere became detached from the baseplate, likely due to peripheral screws not being fully seated.

• Brand Name: DJO SURGICAL
• Common Device Name: GLENOID, HEAD W/RETAINING SCREW, RSP, 32MM/NEUTRAL
• 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: 25294012
• Report Number: 1644408-2026-00990
• Device Sequence Number: 9362256
• Product Code: PHX
• UDI-Device Identifier: 00888912024730
• UDI-Public: 00888912024730
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 05/26/2026

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: 508-32-101
• Device Lot Number: 862C5096
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2025
• 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: 506-03-126 LOT: 506-03-126.; 506-03-138 LOT: 837C1306.; 506-03-138 LOT: 837C1353.; 509-00-032 LOT: 377P2033.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Unknown
• Patient Weight: 133 KG