MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 16X190MM SPL TPR DIST; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	05/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: unknown cone body unknown.Unknown head unknown.G2: foreign: australia.Suggested component code: mechanical (g04) - stem.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a hip arthroplasty surgery and was implanted with zimmer biomet products.Subsequently, the patient was revised due to loosening.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Updated: a1, a2, a3, d1, d2, d4, d6a, d10, g3, g4, g6, h2, h3, h4, h6, h10.D10: 11-301313 arcos con sz c hi 60 mm 569230.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.Review of complaint history found no additional related issues for these items and the reported part and lot combinations.Medical records were not provided.A definitive root cause cannot be determined.The complaint cannot be confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional event information to report at this time.

• Brand Name: ARCOS 16X190MM SPL TPR DIST
• 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: 22213348
• Report Number: 0001825034-2025-01741
• Device Sequence Number: 15640716
• Product Code: KWA
• UDI-Device Identifier: 00880304474277
• UDI-Public: (01)00880304474277(17)321013(10)384840
• 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: 2023
• 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): 07/15/2025

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 Model Number: N/A
• Device Catalogue Number: 11-300916
• Device Lot Number: 384840
• 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: 05/20/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2022
• 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; SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male