MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; ALTIVATE REVERSE GLENOSPHERE 32MM/-6MM W/RETAINING SCREW

Catalog Number	508-32-105
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The agent reported, "revision female 72yrs".The previous surgery and the surgery detailed in this event occurred 1 month, 25 days apart.Item number: 508-32-105.Item description: altivate reverse glenosphere 32mm/-6mm w/retaining screw.Lot number: 4477a1170.Part revision: b.Product type: shoulder.Manufacture date: 10-oct-2025.Expiration date: 28-sep-2030.This evaluation is limited in scope as the item(s) associated with this investigation was not returned to djo surgical - austin for examination.The surgery was completed as intended and without incident and no delay.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.Except for an undocumented nickel allergy.There were no findings during this evaluation that indicate that the reported device(s) was defective.The surgeon performed this procedure to remedy the patient's condition.No further action is deemed necessary.Root cause: the root cause of this complaint is a revision surgery due to unknown reason.No information was submitted with the complaint regarding the patient's pre-existing conditions or any other activities the patient was involved in that may have contributed to the event.There are multiple factors that may contribute to an event that are outside of 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 records (dhr) show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There was a ncmr-77900 associated with the main part # 508-32-105, altivate reverse glenosphere 32mm/-6mm w/retaining screw which document that out of 15 parts lot, 1 part was rejected due to distortion lines on top of part.Later, the rejected part was reworked and accepted after proper justification.All other items in the lot met fit, form and function requirements.The devices were verified to have gone through an acceptable sterilization process and were 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.
Event or Problem Description
Revision surgery - unknown reason.

• Brand Name: DJO SURGICAL
• Common Device Name: ALTIVATE REVERSE GLENOSPHERE 32MM/-6MM 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 ; 5128346313
• MDR Report Key: 24808383
• Report Number: 1644408-2026-00637
• Device Sequence Number: 18811159
• Product Code: KWS
• UDI-Device Identifier: 00190446759898
• UDI-Public: 00190446759898
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 04/07/2026

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: 508-32-105
• Device Lot Number: 4477A1170
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2025
• 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: 509-02-032 LOT: 951W3066.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female