MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS MODULAR REVISION 17X190MM SPL TPR DIST; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Codes	Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, d4, g3, g6, h2, h6 suggested component code: mechanical (g04) stem, h11.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 radiograph was provided but was not sent for mmi review as it was unknown when the x-ray was taken.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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
There is no additional information available at the time of this report.
Event or Problem Description
It was reported that the patient underwent a revision procedure 6 months and 26 days post implantation due to stem subsidence and loosening.Stem was extracted easily and an interlocking 300 arcos was inserted.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).D10: 11-301313 item name arcos con sz c hi 60mm lot # 794770.11-302136 item name arcos lateral troch bolt 36mm lot # 65788861.163667 item name 32mm mod head cocr -6mm neck lot # 64858098.G2: foreign: australia.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.

• Brand Name: ARCOS MODULAR REVISION 17X190MM 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: 19742613
• Report Number: 0001825034-2024-01828
• Device Sequence Number: 3701308
• Product Code: KWA
• UDI-Device Identifier: 00880304480476
• UDI-Public: (01)00880304480476(17)321201(10)65688202
• 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: 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): 10/03/2024

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: 11-300917
• Device Lot Number: 65688202
• 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: 06/21/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2022
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male