MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; RSP BASEPLATE, 30MM, W/P2 COATING

Catalog Number	508-32-204
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	06/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The agent reported doctor did the original reverse shoulder on (b)(6) 2025.The baseplate was discovered to be place too superior on the glenoid.The baseplate center screw was broken and the baseplate was loose.Doctor did the revision and removed the glenoid baseplate, locking screws, glenosphere, 8mm humeral spacer and the poly insert.He implanted the new baseplate more inferior on the glenoid with new locking screws and 36 +10 glenosphere and a new 8mm humeral spacer and +4mm semi constrained poly insert.The broken segment of the baseplated center screw was retained in the glenoid as doctor decided it would cause more bone loss to remove it and it would not compromise fixation of the new baseplate.Male 62.Complaint has been evaluated and is similar to report number 1644408-2022-01390; 508-32-204, s801 - device cracked/broke, 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.
Event or Problem Description
Revision surgery due to broken implant / loosening.

• Brand Name: DJO SURGICAL
• Common Device Name: RSP BASEPLATE, 30MM, W/P2 COATING
• 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: 25586571
• Report Number: 1644408-2026-01205
• Device Sequence Number: 5443245
• Product Code: KWS
• UDI-Device Identifier: 00888912144391
• UDI-Public: 00888912144391
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K112069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 06/22/2026

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: 508-32-204
• Device Lot Number: 769P3751
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2025
• 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: 506-03-114, LOT: 831C2819.; 506-03-122, LOT: 833C2280.; 508-36-107, LOT: 4478A1055.; 509-01-036, LOT: 382P1180.; 510-08-000, LOT: 142G1595.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male