MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; GLENOID, HEAD W/RETAINING SCREW, RSP, 40MM, NEUTRAL

Catalog Number	508-40-101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - doctor increased 40n to 50 +4.Patient has 2b stem in , reason unknown.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to report number 1644408-2021-00481; 508-32-101, s800 - revision surgery, revision surgery.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: GLENOID, HEAD W/RETAINING SCREW, RSP, 40MM, 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 ; 5128346313
• MDR Report Key: 22102178
• Report Number: 1644408-2025-00722
• Device Sequence Number: 15272861
• Product Code: PHX
• UDI-Device Identifier: 00888912144490
• UDI-Public: 00888912144490
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K051075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• 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): 05/28/2025

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 Expiration Date: 03/12/2025
• Device Catalogue Number: 508-40-101
• Device Lot Number: 875C1210
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2019
• 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: 506-03-114 LOT: 831C1652; 506-03-122 LOT: 833C1484; 506-03-130 LOT: 835C1545; 506-03-130 LOT: 835C1545; 508-32-204 LOT: 769P1566
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Sex: Male