MAUDE Adverse Event Report: ZIMMER BIOMED ZIMMER BIOMED ACETABULAR TRIAL RING ; PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL CEMENTED ACETABULAR COMPONENT)

Model Number B 31-108425

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/15/2019

Event Type  malfunction  

Event Description

Zimmer biomed acetabular trial c-ring fell off the device.Occurred on two separate occasions, fell into the open operative site.Fda safety report id# (b)(4).

• Brand Name: ZIMMER BIOMED ACETABULAR TRIAL RING
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL CEMENTED ACETABULAR COMPONENT)
• Manufacturer (Section D): ZIMMER BIOMED ; warsaw IN
• MDR Report Key: 8670502
• MDR Text Key: 147095657
• Report Number: MW5087100
• Device Sequence Number: 1
• Product Code: JDL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B 31-108425
• Device Lot Number: 527930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1