MAUDE Adverse Event Report: ZIMMER BIOMET, INC. +3MM THICKNESS 40MM DIAMETER BEARING; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	110031428
Medical Device Problem Codes	Mechanical Jam (2983); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Insufficient Information (4580); Joint Impingement (4834)
Date of Event	12/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial shoulder arthroplasty on an unknown date.The patient then underwent multiple revision surgeries.Subsequently, the patient underwent a third revision surgery approximately eight (8) months ago do to an unknown reason to revise the poly and tray.Attempt has been made to obtain additional information.No additional information has been received at this time.
Additional Manufacturer Narrative
(b)(4).D10: medical products: item#: sahtne00, +0mm extended neutral humeral tray; lot#: 66892948.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a shoulder revision approximately two (2) months post-implantation due to component impingement.The polyethylene was impinging on a component throughout the range of motion, and the polyethylene insert and tray were exchanged.Prior to this, the patient had an initial shoulder arthroplasty, followed by a first revision for an unspecified reason.A subsequent revision was performed due to concern about loosening; this was later clarified, and the stem was found not to be loose.The issue was identified as component impingement, which led to the later exchange of the polyethylene and tray approximately two (2) months after implantation.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b1; b4; b5; d1; d2; d4; d10; g1; g3; g6; h1; h2; h3; h4; h5; h6; h10.D10: concomitant medical products, part (lot): 110030776 (66528768).The reported event could not be confirmed due to a lack of product/information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.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.

• Brand Name: +3MM THICKNESS 40MM 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: 22828436
• Report Number: 0001822565-2025-02984
• Device Sequence Number: 9522678
• Product Code: PHX
• UDI-Device Identifier: 00887868231599
• UDI-Public: (01)00887868231599(17)280806(10)65854043
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2026

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: 110031428
• Device Lot Number: 65854043
• 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: 07/21/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: H11; SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male