MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 14X150MM SPL TPR DIST; PROSTHETIC, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/09/2023

Event Type  Injury  

Event Description

It was reported that during a bone marrow expansion, the stem was unable to be implanted all the way resulting in a bone fracture, increasing the patient's leg length and increasing the pain in the patient.Because of the femoral fracture, the use of the trochanteric claw and cable was necessary.There is no additional information available at the time of this report.

Manufacturer Narrative

(b)(4).G2: foreign: china.The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: h6 component code: mechanical (g04) - stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Complaint confirmed based on the evaluation of the provided radiograph.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: sizing is appropriate.Femoral component does not appear to be fully seated.Lesser trochanter fracture.No signs of loosening, wear, radiolucency.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.

Event Description

There is no update to the prior event description provided.

• Brand Name: ARCOS 14X150MM SPL TPR DIST
• Type of Device: 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: 18257978
• MDR Text Key: 329621856
• Report Number: 0001825034-2023-02820
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/05/2024

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11-300814
• Device Lot Number: 65886009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 12/04/2023
• Supplement Dates Manufacturer Received: 01/03/2024
• Supplement Dates FDA Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male