MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 15X200MM INTLKNG DIST; PROTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	08/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign: country: australia.Cat# 47249009700 lot# 65908583 tear drop guide wire 3.0 mm diameter 100 cm length cat# 650-1162 lot# 2018110261 delta cer fem hd 32/0mm t1 cat# 166068 lot# 7661349 arcos distal screw ti 5x40mm m cat# 11-301333 lot# 270430 arcos con sz c hi 70mm 270430.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 approximately four months post implantation of a right total hip arthroplasty, the patient was revised due to mid-thigh pain with stem subsidence.No additional information was available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4;g3;h2;h3;h6;h10.H6: component code: mechanical (g04) stem.Visual examination of the provided pictures identified the femoral components and head still in the assembled position which were removed during the revision.Bio debris can be seen around the distal end and at the junction between the cylindrical component and the distal component.No further evaluations could be made based on the provided image alone.No product was returned; 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.The reported products were reviewed for compatibility with no issues noted.Radiograph was provided and reviewed by a health care professional.Review of the available records identified the following: right hip arthroplasty components are anatomically aligned without dislocation.The femoral implant is subsided as the greater trochanter nearly abuts the acetabulum.A distal femoral stem screw is present and appeared fractured.Radiolucency is noted in the subtrochanteric femur likely representing prior osteolysis.Bone quality is osteopenic.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.Based on the medical image review, the complaint is 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
No further event information is available at the time of this report.

• Brand Name: ARCOS 15X200MM INTLKNG DIST
• Common Device Name: PROTHESIS, 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: 20086076
• Report Number: 0001825034-2024-02101
• Device Sequence Number: 12715283
• Product Code: KWA
• UDI-Device Identifier: 00880304475144
• UDI-Public: (01)00880304475144(17)331018(10)65688539
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K100469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 11/15/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11-301815
• Device Lot Number: 65688539
• 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: 08/19/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 98 KG