MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM GLENOSPHERE CEN +0LAT OFS; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	00436003600
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign: japan.H6: proposed component annex g code: mechanical (g04) - head.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that initial operation was performed and an x-ray was taken immediately after the surgery revealed that the glenosphere head had become detached.Therefore, a reoperation was performed on the same day to replace the glenosphere head, and the surgery was completed.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d9; e1; h2; h3; h6 the reported event could not be confirmed due to lack of product/information.No product was returned or pictures provided for the baseplate; visual and dimensional evaluations could not be performed.Visual examination of the returned product/provided pictures identified the glenosphere returned shows signs of use.There is some chatter on the non-articulating surface.There are some scratches on the polished surface also.4 measurements were taken to confirm the device is conforming with the print.Medical records were not provided.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: 36MM GLENOSPHERE CEN +0LAT OFS
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 22903531
• Report Number: 0001822565-2025-03122
• Device Sequence Number: 15431454
• Product Code: PHX
• UDI-Device Identifier: 00889024489479
• UDI-Public: (01)00889024489479(17)340326(10)66552138
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172767
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 00436003600
• Device Lot Number: 66552138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown