MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS STS DIST STEM 14X250MM; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Codes	Difficult to Insert (1316); Inadequacy of Device Shape and/or Size (1583); Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the femoral canal was initially prepared using a 14 mm arcos rigid reamer, followed by reaming to 15 mm with semi-flexible guides.Based on this preparation, a 14 mm arcos-eto stem was selected for implantation.However, after multiple insertion attempts and additional reaming to 15.5 mm with the semi-flexible guides, the stem could not be fully inserted.Continued impaction created a risk of femoral fracture.It was concluded that the stem diameter did not correspond with the labeled specification, and the decision was made to change the implant to a 14 mm sts stem.
Additional Manufacturer Narrative
(b)(4).D10: unknown reamer unknown.G2: foreign: mexico.Suggested component code: mechanical (g04) - stem.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.
Event or Problem Description
No additional information available for the reported event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d4; d5; g3; h2; h3; h4; h6; h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor trends.

• Brand Name: ARCOS STS DIST STEM 14X250MM
• Common Device Name: PROSTHESIS, HIPS
• 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 ; 5745260384
• MDR Report Key: 23864161
• Report Number: 0001825034-2025-04136
• Device Sequence Number: 15975572
• Product Code: KWA
• UDI-Device Identifier: 00880304474536
• UDI-Public: (01)00880304474536(17)340131(10)66349288
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11-301014
• Device Lot Number: 66349288
• 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: 11/26/2025
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2024
• 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 NARRATIVE.
• Patient Sex: Unknown