MAUDE Adverse Event Report: ENCORE MEDICAL L.P DJO SURGICAL; ALTIVATE REVERSE MOD BASEPLATE AND TAPER KIT, 6.5MM WEDGE

Catalog Number	508-65-001
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	04/29/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The agent reported, center post of baseplate broke - glenosphere was detached and 2 peripheral screws broke.Male 67.
Event or Problem Description
Revision surgery due to disassociation / implant breakage.

• Brand Name: DJO SURGICAL
• Common Device Name: ALTIVATE REVERSE MOD BASEPLATE AND TAPER KIT, 6.5MM WEDGE
• 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: 25257011
• Report Number: 1644408-2026-00949
• Device Sequence Number: 5431926
• Product Code: KWS
• UDI-Device Identifier: 00190446822851
• UDI-Public: 00190446822851
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K233481
• 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): 05/22/2026

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: 508-65-001
• Device Lot Number: 5014A1024
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2024
• 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. 5031A1050.; 506-04-118 LOT. 5033A1011.; 506-04-118 LOT. 5033A1013.; 506-04-122 LOT. 5035A1020.; 508-32-103 LOT. 864C6845.; 508-65-030 LOT. 5023A1034.; 509-02-032 LOT. 951W2541.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male