MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS STS DIST STEM 15X250MM; PROSTHESIS, HIP

Catalog Number	11-301015
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign ¿ australia.H6: suggested component code: mechanical (g04) ¿ stem.The product was requested but was not returned by the hospital and will therefore not be sent to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a left hip revision approximately 1-year post implantation due to a broken arcos stem.It was confirmed that no further information could be provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d10; g3; h2; h3; h6.D10: arcos con sz b hi 60mm.Item: 11-301312.Lot: 081790.Unknown claw.Unknown bolt.Visual examination of the provided pictures identified the revised distal stem and proximal cone body components covered in bio debris.The top of the distal stem is seen fractured.The fractured off piece is seen still assembled within the proximal body component.No other observations could be noted using the images alone.No product was returned; further visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: arcos modular femoral revision system exhibiting fracture of the femoral stem taper and disassociation of the proximal cone body and distal femoral stem components with partial pull-out of the stem taper.A risk factor for this complication is lack of fixation of the proximal cone body.Risk factors for lack of fixation of the proximal cone body include generalized reduced bone mineral density and nearby fracture fixation of the greater trochanter.A definitive root cause cannot be determined for the fractured distal stem.It is noted the arcos proximal body and claw assembly was not assembled together using the trochanteric bolt per surgical technique 0529.5-glbl pages 49 - 52.It is not known whether this caused or contributed to the reported event.As per ifu 01-50-0997 en rev.H arcos® femoral revision system it states, improper selection, placement, positioning, alignment, and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components.Zimmer biomet or its affiliates are not liable for complications and/or failure that may arise from the use of the device in circumstances outside of zimmer biomet or its affiliates control including, but not limited to, product selection and deviations from the device¿s indicated uses or surgical technique.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.
Event or Problem Description
It was confirmed that no further information could be provided.

• Brand Name: ARCOS STS DIST STEM 15X250MM
• Common Device Name: PROSTHESIS, HIP
• 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: 23789981
• Report Number: 0001825034-2025-03969
• Device Sequence Number: 5712754
• Product Code: KWA
• UDI-Device Identifier: 00880304480322
• UDI-Public: (01)00880304480322(17)260824(10)988860
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K090757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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): 04/01/2026

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/24/2026
• Device Catalogue Number: 11-301015
• Device Lot Number: 988860
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2016
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 140 KG