MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS CON SZ A STD 50MM SZ A; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Date 05/20/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog number: 11-300924, lot number:304700, brand name: arcos 24x190mm spl tpr dist m.Foreign - chile multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-02324 customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient was revised due to pain, limited range of motion and stem fracture.The surgeon also noted possible metallosis.Attempts have been made and additional information on the reported event is unavailable.

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.The following sections were updated: b4, b5, d10, g4, g7, h1, h2, h3, h6, h10.Visual inspection confirmed the stem to be fractured at the neck.Cone body is also fractured at the opening which receives the stem.The fractured piece of the stem is still assembled with the cone body by the stem screw.The cone body is scratched around the screw hole and neck.Further analysis determined fracture surface artifacts suggest fatigue fracture culminating in bending oveload.Taper stem material to be consistent with ti6-4 titanium alloy.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: mmi report impressions.Fracture of the left hip femoral implant as noted.Complaint sample was evaluated and the reported event was confirmed.Device history record was reviewed and no discrepancies were found.A definitive root cause cannot be determined, however further analysis report suggests fatigue fracture culminating in bending overload.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 CON SZ A STD 50MM SZ A
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10155699
• MDR Text Key: 195953990
• Report Number: 0001825034-2020-02325
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K090757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 11-301300
• Device Lot Number: 925500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 90