MAUDE Adverse Event Report: Encore Medical L.P DJO SURGICAL; ALTIVATE REVERSE GLENOSPHERE 36mm/+4mm W/RETAINING SCREW

Catalog Number	508-36-107
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	07/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to dislocation.
Additional Manufacturer Narrative
The agent reported, "dr (b)(6) had a patient he inherited from dr (b)(6) at (b)(6) hospital.This patient had existing lima humerus and djo glenoid.The patient dislocated.Dr (b)(6) lateralized his glenoid and lengthened the humerus by adding an extension and constrained poly.The patient left surgery very stable.Age 76 gender male." the previous surgery and the surgery detailed in this event occurred 1 month, 13 days apart.Item number: 508-36-107."item description: altivate reverse glenosphere 36mm/+4mm w/retaining screw." lot number: 4478a1238.Part revision: b.Product type: shoulder.Manufacture date: 24-feb-2026.Expiration date: 18-feb-2031.Note: lima-product reported by the customer will be investigated through lima.This evaluation is limited in scope because the reported device was not returned to enovis surgical for evaluation.The surgery was completed as intended and without reported complications.If additional information becomes available, this investigation may be reopened and reassessed.No patient activity, traumatic event, accident, or medical contraindication was reported that may have contributed to the event.There were no findings during this investigation indicating that the reported enovis device was defective.The revision surgery was performed to address the patient's instability/dislocation.Surgical technique / ifu review: the reported construct included implants from multiple manufacturers (lima humeral implant and djo/enovis glenoid component).Enovis does not recommend off-label use involving the combination of enovis implants with implants from other manufacturers unless specifically indicated in the applicable labeling and instructions for use.Based on the information provided, it could not be confirmed whether the mixed-manufacturer construct contributed to the reported instability.Compatibility assessment: the reported shoulder reconstruction consisted of a lima humeral component used in conjunction with a djo/enovis glenoid component.Because the construct involved implants from different manufacturers, compatibility between the components cannot be fully assessed through this complaint investigation.Root cause: the root cause of this complaint was a revision surgery due to dislocation of the shoulder arthroplasty requiring glenoid lateralization, humeral lengthening, and implantation of a constrained polyethylene liner.No information was submitted with the complaint regarding pre-existing patient conditions or patient activities that may have contributed to the event.Additionally, the reported construct consisted of a lima humeral implant used in combination with a djo/enovis glenoid implant.The potential impact of combining implants from different manufacturers cannot be ruled out and may have contributed to the reported issue.There are multiple factors that may contribute to an event that are outside the control of enovis surgical.Containment: inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.The revision surgery was completed successfully.Device history records review: a review of the device history record(s) shows that the reported component(s) used in the previous surgery met design and manufacturing requirements at the time of release for use.There were no nonconforming material reports associated with the product(s) that may have contributed to the reported event.The device(s) was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of the previous surgery.Complaint history: customer complaint history of the reported device(s) showed no present trends or ongoing issues that need review.

• Brand Name: DJO SURGICAL
• Common Device Name: ALTIVATE REVERSE GLENOSPHERE 36mm/+4mm W/RETAINING SCREW
• 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: 50064071
• Report Number: 1644408-2026-01500
• Device Sequence Number: 10121537
• Product Code: KWS
• UDI-Device Identifier: 00190446759904
• UDI-Public: 00190446759904
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K233481
• 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): 07/28/2026

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: 508-36-107
• Device Lot Number: 4478A1238
• 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: 07/09/2026
• Initial Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2026
• 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: Unknown Lot. 2227986.; Unknown Lot. 2541490.; Unknown Lot. 25AT70.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male