MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN G7 LINER; PROSTHESIS, HIP

Model Number N/A

Device Problems Difficult to Remove (1528); Separation Failure (2547)

Patient Problem No Information (3190)

Event Date 10/04/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Multiple mdr's were submitted for this event.Please see report(s): 00018250-2018-00118.Report source: foreign.The event occurred in (b)(6).Not returned to manufacturer.

Event Description

It was reported that during a revision procedure the surgeon had difficulty removing the poly liner.Initially, the surgeon attempted to remove the liner using an extraction tool.When that process failed, a drill and screw was used to remove it.While in the process of removing the liner, the cup migrated.Attempts have been made and no further information is available at this time.

• Brand Name: UNKNOWN G7 LINER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7238966
• MDR Text Key: 98965124
• Report Number: 0001825034-2018-00117
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention