MAUDE Adverse Event Report: ZIMMER BIOMET, INC. +3MM THICKNESS 36MM DIAMETER BEARING; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	110031419
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).D10 narrative: item: 110031399.Lot: 64352554.Item name: mini standard thickness + 0mm taper offset 40mm diameter humeral tray.The product will not be evaluated by zimmer biomet as it remains implanted in the patient.Once the investigation has been completed, a follow up/final report will be submitted.
Event or Problem Description
It was reported from a clinical study that a patient had a right reverse total shoulder arthroplasty performed.The patient did very well throughout the study until reporting severe pain and instability with activities at the 5 year follow up.No treatment or intervention has been reported.Due diligence is in progress.No additional information is available at this time.
Event or Problem Description
It was reported from a clinical study that a patient had a right reverse total shoulder arthroplasty performed.The patient did very well throughout the study until reporting severe pain and instability with activities at the 5 year follow up.There was no specific issues found with the implant nor did the patient have any trauma.There is no planned revision surgery.Due diligence is complete.No additional information is available.
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).The following sections have been updated: b4, b5, e1, e2, e3, g1, g3, g6, h2, h11.The product will not be evaluated by zimmer biomet as it remains implanted in the patient.Once the investigation has been completed, a follow up/final report will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h11.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Crf was provided and reviewed by a health care professional.Review of the available records identified the following: 3 years, x-rays normal , no instability, pain 0/10, ases 81.7, slight pain, moderate problems with usual activity and walking ; 5 years post op: x-rays normal, instability 9/10, pain 8.5/10, ases 30.8, moderate pain and problems walking, slight problems washing/dressing and doing usual activities.Radiographs were indicating to be returning.However, x-ray review is not necessary in this complaint.We have results given to us in the crf from 6 weeks to 5 years postop of image results being ¿normal.¿ obtaining images would not enhance the investigation.A definitive root cause cannot be determined.The reported event is unable to be confirmed.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 is available at the time of this report.

• Brand Name: +3MM THICKNESS 36MM DIAMETER BEARING
• 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: 21731758
• Report Number: 0001822565-2025-00842
• Device Sequence Number: 4046389
• Product Code: PHX
• UDI-Device Identifier: 00887868231506
• UDI-Public: (01)00887868231506(17)240331(10)64291273
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/29/2025

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: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 110031419
• Device Lot Number: 64291273
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: 04/02/2025; 08/28/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 04/23/2025; 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2019
• 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: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Race: White