MAUDE Adverse Event Report: ENCORE MEDICAL L.P DJO SURGICAL; ALTIVATE REVERSE, HUMERAL STEM, SMALL SHELL, SZ 8X48MM

Catalog Number	533-08-048
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	05/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The agent reported, the components were loose.Male 73.Complaint has been evaluated and is similar to report number 1644408-2022-01681; 533-10-108, s810 - device loosening, revision surger.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 loosening.

• Brand Name: DJO SURGICAL
• Common Device Name: ALTIVATE REVERSE, HUMERAL STEM, SMALL SHELL, SZ 8X48MM
• 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: 25383189
• Report Number: 1644408-2026-01072
• Device Sequence Number: 10655183
• Product Code: KWS
• UDI-Device Identifier: 00190446334965
• UDI-Public: 00190446334965
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K190290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/03/2026

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: 533-08-048
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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. UNKNOEN.; 506-04-118, LOT. UNKNOWN.; 508-65-000, LOT. UNKNOWN.; 508-65-030, LOT. UNKNOWN.; 509-02-036, LOT. UNKNOWN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male