MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 16X250MM INTLKNG DIST; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Procedural related complications are influenced by the type of surgery, patients pre-existing comorbidities, and perioperative management.Side effects of the administration of anesthesia are a known cause of chest pain, ekg changes, and myocardial infarction (heart attack) during the intraoperative and postoperative recovery.Elective total joint patients typically have a cardiac workup prior to surgery to assess the patient¿s physical readiness for surgery, hence reducing their risk for these cardiac related complications.In addition, the femoral canal is broached which causes bleeding but allows for the femoral stem to be impacted into place.This combination of stress in addition to anesthesia can cause a hypotensive episode and require specialized treatment.As the reported complaint indicated, a cardiac intraoperative complication developed, and medical treatment was warranted to treat the complication.The patient was stabilized with no further issues reported.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
It was reported that the patient coded when the stem was implanted.The patient was stabilized after the event and the implant remains implanted.There is no additional information available at the time of this report.

• Brand Name: ARCOS 16X250MM INTLKNG 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: 20469733
• Report Number: 0001825034-2024-02462
• Device Sequence Number: 7471693
• Product Code: KWA
• UDI-Device Identifier: 00880304475212
• UDI-Public: (01)00880304475212(17)340325(10)66431015
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K100469
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/15/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11-301916
• Device Lot Number: 66431015
• 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: 09/27/2024
• Initial Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/29/2024
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Prefer Not To Disclose