MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 GLENOSPHERE 40+4; SHOULDER IMPLANT - GLENOSPHERE

Catalog Number	550540004
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994)
Date of Event	02/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient came in complaining of pain a 1-2 weeks ago.A ct scan was done and it was discovered that the enhance reverse liner could be seen floating in the shoulder and was not attached to the humeral shell/stem construct.It also showed what appeared to be metallosis indicating that the glenosphere had been rubbing on the face of the humeral shell.Revision surgery was done on (b)(6) 2025.There was a significant amount of metal debris and metallosis on the bone and the surrounding tissue.It is unknown how long the poly had been out of place but by the damage done to the implants as well as the amount of metallosis, it seemed to have happened quite a while back.The glenosphere had worn a divot in the face of the shell.Surgeon was able to remove the glenosphere, the humeral shell, the stem, and retrieved the poly.The baseplate and screws were well fixed and stayed implanted.The surgeon cleaned/removed the metal debris and metallosis out of the bone and tissue.The surgeon was able to revise to a larger and longer stem and achieve good fixation, he put on a new glenosphere of the same size and trailed a few humeral shell and poly combinations to determine what was best.When x-raying to check our positioning of new parts, an acromial fracture could be seen.The preferred combination of a +8 humeral shell for an xl stem and a 40 +0 retentive liner was chosen and implanted by the surgeon.Doi: unknown, affected side: right shoulder.
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 medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A manufacturing record evaluation (nc search) was performed for the finished device product code: 550540004, lot -341349 and no non-conformances / manufacturing irregularities were identified.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: a manufacturing record evaluation (nc search) was performed for the finished device product code: 550540004, lot -341349 and no non-conformances / manufacturing irregularities were identified.

• Brand Name: GLENOSPHERE 40+4
• Common Device Name: SHOULDER IMPLANT - GLENOSPHERE
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21551959
• Report Number: 1818910-2025-03646
• Device Sequence Number: 8165167
• Product Code: PHX
• UDI-Device Identifier: 10603295547150
• UDI-Public: (01)10603295547150(17)280229(10)341349
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K212737
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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: 550540004
• Device Lot Number: 341349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male