MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; ALTIVATE REVERSE, HUMERAL STEM, STANDARD SHELL, SZ 6X108MM

Catalog Number	530-06-108
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/31/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The agent reported revidion for post fracture reverse construct.Cemented in stem fell into valgus 3 yrs post op.Perforated humeral cortex medially.Stem replaced with stryker stem and 36mm glenosphere complaint has been evaluated and is similar to report number 1644408-2019-01291; 530-10-220, s800 - revision surgery, revision surgery 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 post fracture reverse construct.Cemented in stem fell into valgus 3 yrs post op.Perforated humeral cortex medially.Stem replaced with stryker stem and 36mm glenosphere.

• Brand Name: DJO SURGICAL
• Common Device Name: ALTIVATE REVERSE, HUMERAL STEM, STANDARD SHELL, SZ 6X108MM
• 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: 24974725
• Report Number: 1644408-2026-00768
• Device Sequence Number: 14697189
• Product Code: HSD
• UDI-Device Identifier: 00888912168243
• UDI-Public: 00888912168243
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K141990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 04/23/2026

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: 530-06-108
• Device Lot Number: 923W1394
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2023
• 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: 508-32-103 LOT: 864C5923; 508-32-204 LOT: 769P2759; 509-02-032 LOT: 951W2173
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female