MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 17X150MM SPL TPR DIST; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the proximal part of the implant failed to connect to the distal part.A larger one (70mm) was used to continue the procedure with the same distal stem.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).D10: 11-301303, item name arcos con sz c std 60mm , lot # 65760480.G2: foreign: china, customer has indicated that the product will not be returned zimmer biomet for investigation as it remains implanted.Once the investigation has been completed, a follow-up mdr will be submitted.Report was initially submitted jan 13, 2025 but third acknowledgement was missing.Attempted to resubmit the 14th and the acknowledgement was still missing so we reached out to the fda via cesub on january 14th.We receive a response back from the fda (cesub) on jan 22, 2025 indicating the third acknowledgement failed due to a space in the udi number in d4 which caused an invalid xml.Received further correspondence from the fda on jan 24, 2025 asking us to notate what occurred in h11, make the udi correction and it would not be considered a late report submission.
Event or Problem Description
There is no update to the prior event description provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, g3, g6, h2, h6: proposed component code: mechanical (g04)- stem, h11: visual examination of the returned product identified scratches are noted in the taper hole, proximal end, trunnion, and neck.Threads and counterbore show damage including thread deformation and gouges from use.No other damage was noted.Where measured, the device was conforming to specification.The distal stem was not returned.Both devices were 100% inspected during manufacturing and conforming for the mating ends.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot be determined.This complaint cannot be confirmed.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 for trends.

• Brand Name: ARCOS 17X150MM SPL TPR DIST
• Common Device Name: PROSTHETIC, 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: 21231207
• Report Number: 0001825034-2025-00121
• Device Sequence Number: 8722175
• Product Code: KWA
• UDI-Device Identifier: 00880304474253
• UDI-Public: (01)00880304474253(17)330718(10)66031288
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K090757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 05/12/2025

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: 11-300817
• Device Lot Number: 66031288
• 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: 12/16/2024
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2023
• 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: PLEASE SEE H11.
• Patient Sex: Unknown