MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; ALTIVATE REVERSE, HUMERAL STEM, SMALL SHELL, SZ 10X108MM

Catalog Number	533-10-108
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Revision surgery - due to infection.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to report number 1644408-2022-01248; 533-10-108, s808 - infection, 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, SMALL SHELL, SZ 10X108MM
• 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 ; 5128346313
• MDR Report Key: 21770082
• Report Number: 1644408-2025-00343
• Device Sequence Number: 9748834
• Product Code: KWS
• UDI-Device Identifier: 00190446259152
• UDI-Public: 00190446259152
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K172351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2025

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 Expiration Date: 01/04/2025
• Device Catalogue Number: 533-10-108
• Device Lot Number: 929W1104
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2019
• 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: 520-50-018 LOT: 929C1108.; 533-01-002 LOT: 010Y1005.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male