MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 GLENOSPHERE 36+8; SHOULDER IMPLANT - GLENOSPHERE

Catalog Number	550536008
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
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 glenosphere screw would not lock in to baseplate.Doe: (b)(6) 2025.Affected side: left shoulder.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information provided: "it was reported that glenosphere screw would not lock in to baseplate".The product was returned to depuy synthes for evaluation.Visual inspection of the glenosphere 36+8 found the following conditions on its surface: 1) signs of assembly attempts on its overall surface; 2) the inner threads of the glenosphere and the threads of the locking screw were found slightly stripped; 3) the star driver connection was found worn/deformed; 4) the central peg of the glenosphere had deformation patterns on its cylindrical edges; and 5) a foreign matter/debris was found near the device inner threads.No other cosmetic anomaly was noted.Damage observed on the threads can be consistent with an off-axis assembly; overtightening of the device with its mating components; or by impacting the device before it was fully seated.As for the deformations observed on the peg, potential cause can be traced to improper handling/care during the assembly process, where excessive force or a misaligned assembly could have contributed to this kind of damage.Properly handling and¿attention to the approved use of the device diminishes the risk of failure.Please review the inhance¿ shoulder system ¿ surgical technique (500992014 rev c), page 41, for the considerations specified on the definitive glenosphere placement.Furthermore, for the foreign matter/debris observed, potential cause can be traced to maintenance due to improper cleaning/sterilization process.A manufacturing record evaluation was performed for the finished device 333111 lot number, and no non-conformances nor manufacturing irregularities were identified.A dimensional inspection was performed and met specifications*.A functional test was unable to be performed due to the post-manufacturing damage and as the baseplate was not returned for evaluation.However, taking in consideration the damage observed on the device peg and threads, it is reasonable to consider a difficulty on the assembly between the device (glenosphere 36+8) with its mating device (baseplate).The overall complaint was confirmed as the observed condition of the glenosphere 36+8 was contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.Drawing/specifications reviewed? (b)(4).Dimensional inspection: specified dimensions locking screw total length = 22.75 mm ± 0.225 mm.Locking screw length (top to second set of threads) = 14.75 mm ± 0.125 mm.Locking screw bottom diameter ø = 3.800 mm ± 0.025 mm.Locking screw upper diameter ø = 4.500 mm ± 0.025 mm.Glenosphere diameter (section n-n) ø = 31.069 mm ± 0.150 mm.Glenosphere upper diameter (on convex surface) ø = 5.500 mm ± 0.050 mm.Glenosphere peg diameter ø = 7.100 mm ± 0.050 mm.Glenosphere drill diameter (near the peg) ø = 4.000 mm ± 0.13 mm.Measured dimensions: locking screw total length = 22.77 mm (complies).Locking screw length (top to second set of threads) = 14.83 mm (complies).Locking screw bottom diameter ø = 3.80 mm (complies).Locking screw upper diameter ø = 4.48 mm (complies).Glenosphere diameter (section n-n) ø = 31.12 mm (complies).Glenosphere upper diameter (on convex surface) ø = 5.46 mm (complies).Glenosphere peg internal diameter ø = 7.09 mm (complies).Glenosphere drill diameter (near the peg) ø = 3.95 mm & 3.97 mm (complies).Devices used: digimatic caliper cd78620.3.95 mm pin gauge.3.97 mm pin gauge.Device history lot: a manufacturing record evaluation was performed for the finished device 333111 lot number, and no non-conformances nor manufacturing irregularities were identified.H11 additional narrative: corrected: h3.

• Brand Name: GLENOSPHERE 36+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: 23746623
• Report Number: 1818910-2025-21398
• Device Sequence Number: 14928736
• Product Code: PHX
• UDI-Device Identifier: 10603295546696
• UDI-Public: (01)10603295546696(10)333111
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K212737
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 12/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 550536008
• Device Lot Number: 333111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 12/26/2025
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male