MAUDE Adverse Event Report: ENCORE MEDICAL LP DJO SURGICAL; GLENOID, HEAD W/RETAINING SCREW, RSP, 36MM, NEUTRAL

Model Number	508-36-101
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation: the agent reported: "patient presented two years post op for reverse total shoulder.Patient showed symptoms of dislocation.Surgeon opted to revise to larger glenosphere and liner.When original liner was exposed, it was determined that it was disengaged from the stem".The previous surgery and the surgery detailed in this event occurred 2 years, 12 days apart.Item number: 508-36-101 item description: glenoid, head w/retaining screw, rsp, 36mm, neutral lot#: 869c4311 part revision: f product type: shoulder manufacture date: 18-mar-2024 expiration date: 11-mar-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.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.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 was a revision surgery due to disengagement of the humeral liner from the stem, resulting in dislocation symptoms.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) shows that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There was an (ncmr#(b)(4) associated with the main part 508-36-101 (item description: [insert item description if needed]), which documents that out of 75 parts in the lot, 48 parts were accepted and 27 parts were identified for rework due to scratches and surface finish defects.The affected parts were reworked in accordance with established procedures and subsequently accepted following inspection and proper justification.All other items in the lot met fit, form, and function requirements.The devices were verified to have undergone an acceptable sterilization process and were within their 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
Patient presented two years post op for reverse total shoulder.Patient showed symptoms of dislocation.Surgeon opted to revise to larger glenosphere and liner.When original liner was exposed, it was determined that it was disengaged from the stem.

• Brand Name: DJO SURGICAL
• Common Device Name: GLENOID, HEAD W/RETAINING SCREW, RSP, 36MM, NEUTRAL
• Manufacturer (Section D): ENCORE MEDICAL LP; 9800 metric blvd.; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL LP; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: stacey bonnell ; 9800 metric blvd.; austin, TX 78758 ; 8003219549
• MDR Report Key: 25429204
• Report Number: 1644408-2026-01124
• Device Sequence Number: 10322555
• Product Code: PHX
• UDI-Device Identifier: 00888912024761
• UDI-Public: 00888912024761
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K051075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 06/08/2026

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 Model Number: 508-36-101
• Device Lot Number: 869C4311
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 509-01-436 390P1208
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male