MAUDE Adverse Event Report: Zimmer Biomet, Inc. MODULAR POST TM; Prosthesis, shoulder, semi-constrained, metal/polymer cemented

Catalog Number	SAGP0002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent initial right total shoulder arthroplasty approximately 1 year and 8 months ago.Approximately four months later, developed right shoulder pain after working on a fence, which resolved approximately three months later.Several months afterward, the pain recurred, and the patient received a steroid injection to the right shoulder and was prescribed meloxicam.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event.Associated reports are available for the applicable concomitant products below: d10: associated product information, part (lot): -sagl2043 (66422718).The customer has not indicated whether the product will be zimmer biomet for investigation, and the product location is unknown.The investigation is in process.Once the investigation has been completed, a supplemental medwatch 3500a will be submitted.

• Brand Name: MODULAR POST TM
• Common Device Name: Prosthesis, shoulder, semi-constrained, metal/polymer cemented
• 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 ; +1(574)526-0384
• MDR Report Key: 50255856
• Report Number: 0001822565-2026-02862
• Device Sequence Number: 16014247
• Product Code: KWS
• UDI-Device Identifier: 00889024574496
• UDI-Public: (01)00889024574496(17)340610(10)66616692
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K191814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: SAGP0002
• Device Lot Number: 66616692
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2026
• Initial Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2024
• 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 Sex: Female
• Patient Weight: 160 LB