MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 16X150MM SPL TPR DIST; PROSTHESIS, HIP

Model Number N/A

Device Problem Mechanical Problem (1384)

Patient Problem No Code Available (3191)

Event Date 01/23/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: 31-301852-arcos 3.5mm hex drive-zb170702.31-301311-arcos con sz a hi 60mm trl-515910.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-00994.0001825034-2020-00995.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, during the initial surgery the cone body trial hex screw stripped, and the hex driver tip broke off inside cone body.Trial cone body could not be removed from the distal stem implant.Surgeon removed distal stem and trial cone body from patient.The case was completed with another distal stem.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

Upon reassessment of the reported event, it was determined to be not reportable.The cone body trial hex screw stripped and the hex driver broke which led to the stem having to be removed.No allegation against the stem.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Upon reassessment of the reported event, it was determined to be not reportable.The cone body trial hex screw stripped and the hex driver broke which led to the stem having to be removed.No allegation against the stem.

• Brand Name: ARCOS 16X150MM SPL TPR DIST
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9804775
• MDR Text Key: 189302138
• Report Number: 0001825034-2020-00996
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K090757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 07/10/2020

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: 11-300816
• Device Lot Number: 750200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/12/2020
• Initial Date FDA Received: 03/09/2020
• Supplement Dates Manufacturer Received: 06/24/2020
• Supplement Dates FDA Received: 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention