MAUDE Adverse Event Report: Zimmer Biomet, Inc. HUMERAL STEM MICRO SIZE 12; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

Catalog Number	SAHS1212
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Periprosthetic fracture (4902)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10.Concomitant medical products.Unk stem trial part: unk lot: unk g2: foreign - event occurred in japan.H6.Component code: mechanical (g04) - stem.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 follow-up mdr will be submitted.If any further information is found that 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
It was reported a postoperative humeral shaft fracture was identified following an initial procedure involving a humeral stem.The fracture was discovered during a postoperative follow-up examination.The surgeon noted an unusual sensation during provisional reduction in the initial surgery and commented that a crack may have initiated at that time.The patient was planned to undergo fixation with a plate, contingent on the absence of stem loosening.No further information has been provided.

• Brand Name: HUMERAL STEM MICRO SIZE 12
• Common Device Name: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
• 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: 50854738
• Report Number: 0001822565-2026-03207
• Device Sequence Number: 15827167
• Product Code: MBF
• UDI-Device Identifier: 00889024627260
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K213856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 09/22/2026

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: SAHS1212
• Device Lot Number: 67261769
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2025
• 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: Unknown