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

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Separation Failure (2547)

Patient Problem No Information (3190)

Event Date 10/04/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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):0001825034 -2018 -00117.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 CUP
• 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: 7239055
• MDR Text Key: 98966578
• Report Number: 0001825034-2018-00118
• Device Sequence Number: 1
• Product Code: KWA
• 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