MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS STS DIST STEM 17X250MM; PROSTHESIS, HIP

Catalog Number	11-301017
Medical Device Problem Codes	Unstable (1667); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Synovitis (2094); Inadequate Osseointegration (2646); Medical device site infection (4845); Hemarthrosis (4889)
Date of Event	09/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revisions surgery approximately 2 months post-implantation due to pre-existing conditions of infection, synovitis, stiffness, and an open wound.During the procedure, it was noted that the wound was draining and a large caliber vein on the posterior distal thigh was bleeding.The femoral component had rotation instability, and the patient underwent a revision of the stem, head, and liner without complication.Follow-ups to gather additional information are currently in process.
Additional Manufacturer Narrative
(b)(4).A2: patient born on unknown day in 1964.D10: unknown head.Unknown liner.G7 osseoti multihole 66mm i.Item: 110010271.Lot: 6987122.Bone screw self-tapping 6.5 mm dia.20 mm length.Item: 00625006520.Lot: 66240757.Bone screw self-tapping 6.5 mm dia.30 mm length.Item: 00625006530.Lot: j7887639.Bone screw self-tapping 6.5 mm dia.30 mm length.Item: 00625006530.Lot: j7896143.H6: proposed component code: mechanical (g04) - stem.The location of the reported product is unknown at this time; therefore, it will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d4; 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 records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: ¿patient had ct scan of pelvis/abdomen which displayed signs of infection.¿a culture report identified body fluid culture: 1 organism; candida glabrata.Gram stain: few white blood cells seen, no organisms seem.Anaerobic culture: no growth after 5 days.¿patient had a revision surgery.Patient presented with bleeding from hip and aspiration results indicate infection, synovitis and stiffness and open wound which are all pre-existing conditions.A large caliber vein on posterior distal thigh was bleeding.Femoral component was revised for gross rotational instability.Antibiotics provided for infected joint replacement.No other complication noted.The reported infection is considered not device related as the patient entered the study with a periprosthetic infection which recurred after placement and is therefore considered a pre-existing condition unrelated to implanted devices.It was also noted the chronic ongoing infections can impact bone quality, inability to develop bone/implant integration and/or septic loosening, therefore impacting the implant's stability within the bone.An off-label use was noted as the surgeon implanted zimmer biomet devices in an ongoing infection.Ifu 01-50-0997 state - absolute contraindications include: infection.And is therefore considered off-label use.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
No additional information available for the reported event.

• Brand Name: ARCOS STS DIST STEM 17X250MM
• 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: 23406735
• Report Number: 0001825034-2025-03392
• Device Sequence Number: 15736080
• Product Code: KWA
• UDI-Device Identifier: 00880304480353
• UDI-Public: (01)00880304480353(17)340520(10)66540808
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K090757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,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 Catalogue Number: 11-301017
• Device Lot Number: 66540808
• 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: 10/03/2025
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2024
• 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
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White