MAUDE Adverse Event Report: Zimmer Biomet, Inc. COMP RVS HMRL TI TRAY 44MM; Shoulder Prosthesis, Reverse Configuration

Catalog Number	115340
Medical Device Problem Codes	Fracture (1260); Noise, Audible (3273)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision of a left reverse total shoulder arthroplasty.It was reported that the patient had a history of prior revisions of the same shoulder construct.The reported reason for the current revision was a fracture of the humeral tray, occurring approximately 6.5 years post-implantation, which the patient described as a metallic snap while putting on a jacket, after which the patient presented to the clinic.It was reported that during the revision, the taper could not be removed from the humeral shaft, so the taper junction and humeral components were explanted and exchanged.No additional patient harm was reported.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4) g2: foreign - event occurred in germany.The 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.

• Brand Name: COMP RVS HMRL TI TRAY 44MM
• Common Device Name: Shoulder Prosthesis, Reverse Configuration
• Manufacturer (Section D): Zimmer Biomet, Inc.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): Zimmer Biomet, Inc.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; +1(574)526-0384
• MDR Report Key: 50056830
• Report Number: 0001825034-2026-02199
• Device Sequence Number: 18444542
• Product Code: PHX
• UDI-Device Identifier: 00880304475335
• UDI-Public: (01)00880304475335(17)290823(10)160640
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K193373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/28/2026

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
• Device Catalogue Number: 115340
• Device Lot Number: 160640
• Was Device Available for Evaluation?: Yes
• 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: 07/02/2026
• Initial Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2019
• 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: Male