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

Model Number N/A

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

Patient Problem No Code Available (3191)

Event Date 05/18/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.Medical devices: item number: 110010262, item name: g7 multihole shell, lot #: 6243619, item number: 010000847, item name: g7 liner, lot #: 6108986, item number: 51-149080, item name: taperloc stem, lot #: 3892043, item number: 010000999, item name: g7 screw, lot #: 6025553.Foreign - event occurred in (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 04022, 0001825034 - 2018 - 04023, 0001825034 - 2018 - 04024.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the liner would not seat with the acetabular shell.Shell and liner were removed and replaced.Surgery was delayed by approximately 1-2 hours.Attempts have been made and no additional information is available.

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was not confirmed.The returned product was evaluated against the complaint.The liner and 3hole shell were assembled upon receipt.The flush profile of the liner and 3 hole assembly implies that the liner is fully seated.The liner could not be removed by hand.No motion of any kind was felt or observed during the attempts to remove the liner from the shell.Indentations and scratches were found on the liner's rim.Dhr was reviewed and no discrepancies were found.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.

Event Description

No further event information available at the time of this report.

• Brand Name: G7 SHELL
• 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: 7603602
• MDR Text Key: 111136985
• Report Number: 0001825034-2018-04021
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK140669
• 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,Followup
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 110010242
• Device Lot Number: 6250495
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/18/2018
• Initial Date FDA Received: 06/14/2018
• Supplement Dates Manufacturer Received: 01/16/2019
• Supplement Dates FDA Received: 01/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2018
• 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): Required Intervention