MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL E1 LINER; PROSTHESIS, HIP

Model Number N/A

Device Problems Difficult to Insert (1316); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated the product is in the process of being returned for investigation.Once the investigation has been completed, a follow up mdr will be submitted.Concomitant medical products: item (b)(4), g7 pps ltd acet shell 54f, lot 3878790.

Event Description

It was reported that the surgeon could not seat the liner into the g7 cup.Surgeon verified liner was proper match for the cup, but was unable to seat after several attempts.No adverse event was reported regarding the patient.Additional information was requested and received.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned device revealed gouging around the scallops of the liner and circular indentations were found on the outer radius that indicate a screw came in contact with the liner during attempts at impaction.No dimensional analysis will be performed due to the impaction of the liner.Device history record (dhr) was reviewed and no discrepancies were found.Root cause of the event could not be determined.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.

• Brand Name: G7 HI-WALL E1 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: 7355359
• MDR Text Key: 103157932
• Report Number: 0001825034-2018-02041
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/05/2019
• Device Model Number: N/A
• Device Catalogue Number: 010000935
• Device Lot Number: 3467512
• Other Device ID Number: (01) 00880304527102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2014
• 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