MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 18X190MM SPL TPR DIST M; PROSTHESIS, HIP

Model Number N/A

Device Problem Migration (4003)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924)

Event Date 08/10/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: foreign country: (b)(6).The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient underwent a right hip procedure.Subsequently, the patient was revised approximately 1 week later due to a femur fracture.The surgeon stated that the original arcos stem had penetrated and fractured the back wall of the femur.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: a longitudinal periprosthetic fracture of the femoral diaphysis extending to the tip of the femoral implant.On the lateral view, the implant extends beyond the posterior cortical margin of the femur.Bone quality is markedly osteopenic.The femoral implant is loose secondary to the periprosthetic fracture.It is unknown if the loosening happened prior or after the fracture.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.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 18X190MM SPL TPR DIST M
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12383244
• MDR Text Key: 268658142
• Report Number: 0001825034-2021-02499
• Device Sequence Number: 1
• Product Code: MAY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K090757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11-300918
• Device Lot Number: 281610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN CUP; UNKNOWN HEAD; UNKNOWN LINER; UNKNOWN CUP; UNKNOWN HEAD; UNKNOWN LINER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male