MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 GLENOSPHERE 40+8; SHOULDER IMPLANT - GLENOSPHERE

Catalog Number	550540008
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the patient was revised due to glenosphere being dislodged from baseplate.The locking screw was still screwed into baseplate with no damage to any of the threads.It was stated that the glenosphere were loose.Loosening interface was marked as non-cemented.Affected side: right shoulder.
Additional Manufacturer Narrative
Product complaint # (b)(4) investigation summary patient was revised due to glenosphere dislodged from baseplate.Locking screw was still screwed into baseplate with no damage to any of the threads.It was stated that the glenosphere were loose.Loosening interface was marked as non-cemented.The product was returned to depuy synthes for evaluation.Visual inspection of the returned device found that the central screw of the glenosphere 40+8 was disassemble and no significant damaged that could contribute to the reported event were observed on the threaded portion.However, the inner threads of the glenosphere shows signs of damage and cross threaded, consistent with excessive force applied during the assembling/disassembling process that overload the device material.Furthermore, the reverse liner shows signs of heavy wear in one of the sides caused by the reported disassociation of the glenosphere and baseplate.As per surgical technique inhance¿ shoulder system (500992014 rev c), page 41, the next precautions need to be followed while assembling and disassembling the device with its mating component: 1) "to place the definitive glenosphere, assemble the glenosphere inserter tip to the baseplate inserter rod.Next, thread the inserter tip into the selected glenosphere until it is snug.Care should be taken not to overtighten.Navigate the glenosphere taper into the baseplate and impact the baseplate inserter rod to seat the glenosphere"; and 2) "prior to removing the glenosphere inserter tip, twist and pull to ensure that the taper is fully seated.Please note that if the glenosphere inserter tip is left behind when unthreading the baseplate inserter rod, the star driver 30 can be utilized to remove the inserter tip".A functional test was not performed since it was not applicable to the complaint condition.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the glenosphere 40+8 would have contributed to the complained issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is required.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot a search of the depuy synthes nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.H11 additional narrative: added: d10 corrected: h3.

• Brand Name: GLENOSPHERE 40+8
• Common Device Name: SHOULDER IMPLANT - GLENOSPHERE
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23346657
• Report Number: 1818910-2025-17869
• Device Sequence Number: 9544853
• Product Code: PHX
• UDI-Device Identifier: 10603295547174
• UDI-Public: (01)10603295547174(17)270831(10)333369
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K212737
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 550540008
• Device Lot Number: 333369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/26/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2022
• 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: REVERSE HUMERAL SHELL L 40+8; REVERSE LINER 40+4 R; UNKNOWN SHOULDER GLENOSPHERE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 107 KG