MAUDE Adverse Event Report: BIOMET, INC. ARCOS; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Device Problem Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/03/2018

Event Type  malfunction  

Event Description

Hip implant consists of 2 modular components that must be joined at the surgical field.Surgeon (familiar with device) and vendor were present at field and components were joined by standard torque wrench.However, the components did not fully seat properly.

Event Description

Hip implant consists of 2 modular components that must be joined at the surgical field.Surgeon (familiar with device) and vendor were present at field and components were joined by standard torque wrench.However, the components did not fully seat properly.

• Brand Name: ARCOS
• Type of Device: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• Manufacturer (Section D): BIOMET, INC.; 56 east bell dr.; p.o. box 587; warsaw IN 46582
• MDR Report Key: 7909750
• MDR Text Key: 121798818
• Report Number: 7909750
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 09/13/2018,06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2018
• Patient Sequence Number: 1