MAUDE Adverse Event Report: Encore Medical L.P. DJO SURGICAL; ALTIVATE REVERSE, HUMERAL STEM, STANDARD SHELL, SZ 14X108mm

Catalog Number	530-14-108
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	09/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - patient revised due to stem loosening and shoulder instability.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to report number 1644408-2018-00406; 530-08-108, s810 - device loosening, s814 - stability, poor joint, 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: ALTIVATE REVERSE, HUMERAL STEM, STANDARD SHELL, SZ 14X108mm
• 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: 50812266
• Report Number: 1644408-2026-01917
• Device Sequence Number: 10590016
• Product Code: HSD
• UDI-Device Identifier: 00888912168489
• UDI-Public: 00888912168489
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K141990
• 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): 09/17/2026

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: 530-14-108
• Device Lot Number: 415T1668
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2026
• 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: 508-36-107 Lot: 4478A1287; 509-00-036 Lot: 378P2007
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 75 YR
• Patient Sex: Male