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

Catalog Number	508-65-000
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Complaint - doctor dr (b)(6) went to trial the glenosphere in the patient, and the taper in the arg baseplate did not seat.Doctor ensured that all of the bone and tissue was cleared away to get the glenosphere trial down.He tried multiple times and was unsuccessful.Doctor also put the trial 36 +4 glenosphere trial in and the inserter handle cold fused when he was trying to get the glenosphere to engage.After multiple attempts with the taper that comes in the arg baseplate, doctor had the extra taper opened, and we continued to have this problem.At this point, we called an engineer and she suggest we take the baseplate out and put a new one in.When the screws were removed from this baseplate, the threads got damaged, and he ended up replacing all of the peripheral screws.There was a 45-60-minute delay in surgery.
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

• Brand Name: DJO SURGICAL
• Common Device Name: ALTIVATE REVERSE MOD BASEPLATE AND TAPER KIT, 6.5MM 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 ; +1(512)834-6313
• MDR Report Key: 24510091
• Report Number: 1644408-2026-00365
• Device Sequence Number: 10486547
• Product Code: KWS
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K233481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 508-65-000
• Device Lot Number: 5008A1188
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2025
• 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: 5031A1042; 506-04-114 LOT: 5031A1162; 506-04-126 LOT: 5037A1084; 506-04-130 LOT: 5039A1077; 508-65-100 LOT: 5019A1072
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male