MAUDE Adverse Event Report: ZIMMER BIOMET, INC. +6MM LATERAL OFFSET 40MM DIAMETER GLENOSPHERE; PROSTHESIS, SHOULDER

Catalog Number	110030778
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).H6: mechanical (g04), head.D10: standard 40mm diameter bearing cat# 110031421 lot# 66725039.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that a patient has had a history of multiple revisions of a right reverse shoulder that was initially implanted approximately 6 years ago.The most recent revision occurred approximately 1 month ago, and the patient was scheduled to have another revision due to dislocation approximately 2 weeks ago; however, no revision has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided for this event, but other medical records were provided and reviewed by a healthcare professional and a timeline was created.Review of the available records identified the following: (b)(6) 2025; follow up ¿ patient reported his shoulder didn¿t feel right and as though it was out again with the clicking returned.(b)(6) 2025; follow up ¿ x-rays showed patient had again dislocated anteriorly ¿ ¿surgery is expected to be friday (b)(6) 2025, with procedure(s) and components dependent on culture results.¿ contributing factors of event: ¿ multiple revisions due to recurrent dislocation.Patient also reports he has a history of tha dislocations.A definitive root cause cannot be determined.Contributing factors of event: multiple revisions due to recurrent dislocation.Patient also reports he has a history of tha dislocations.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: +6MM LATERAL OFFSET 40MM DIAMETER GLENOSPHERE
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21642433
• Report Number: 0001822565-2025-00665
• Device Sequence Number: 7574105
• Product Code: PHX
• UDI-Device Identifier: 00887868231278
• UDI-Public: (01)00887868231278(17)340417(10)66258833
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2025

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: Lay User/Patient
• Device Catalogue Number: 110030778
• Device Lot Number: 66258833
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2024
• 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: SEE H11.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Male