MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TM REVERSE LINER IMPACTOR 36MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	00430902900
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Post Operative Wound Infection (2446); Foreign Body In Patient (2687)
Date of Event	05/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent a reverse total shoulder arthroplasty to treat a proximal humerus fracture, after which metal fragments were detected on follow-up imaging and surgery to remove them was scheduled.Postoperative radiographs immediately after the procedure were reported as normal.During a routine follow-up approximately one month post-implantation, radiographs showed metal fragments, and a procedure to remove the residual fragments was scheduled.The patient developed an infection at the site where the fragment remains.The patient was scheduled for surgical removal of the fragments.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in japan.H6: proposed component code: mechanical (g04) - impactor.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

• Brand Name: TM REVERSE LINER IMPACTOR 36MM
• 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: 25472065
• Report Number: 0001822565-2026-01874
• Device Sequence Number: 10465742
• Product Code: PHX
• UDI-Device Identifier: 00889024267336
• UDI-Public: 00889024267336
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K052906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/11/2026

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: 00430902900
• Device Lot Number: N/A
• 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: 05/15/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Male