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	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to periprosthetic fracture.
Additional Manufacturer Narrative
The agent reported revision surgery due to periprosthetic fracture.Complaint has been evaluated and is similar to report number 1644408-2021-00134; 530-08-048, s800 - revision surgery, 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 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 ; 5128346313
• MDR Report Key: 25553160
• Report Number: 1644408-2026-01192
• Device Sequence Number: 10751693
• Product Code: KWS
• UDI-Device Identifier: 00190446334965
• UDI-Public: 00190446334965
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K190290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 06/18/2026

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: 1491A1078
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/26/2020
• 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: 831C1887; 506-03-114 LOT: 831C1887; 506-03-130 LOT: 835C2744; 508-32-103 LOT: 864C4292; 508-32-204 LOT: 769P1752; 509-02-032 LOT: 951W1441
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female