MAUDE Adverse Event Report: ZIMMER BIOMET, INC. IT XLPE LINER; PROSTHESIS, HIP

Model Number N/A

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

Patient Problem No Code Available (3191)

Event Date 04/11/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00885201836, it vite xlpe liner, 63097093; 00875706802, shell with multi holes porous 68 mm, 63616005.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 02436.

Event Description

It was reported that during a total hip revision procedure, while attempting to seat the liner into a new cup, it would not seat properly and sat eccentric.Screws and tissue were checked, with no issues noted.Liner still sat proud on second attempt.A second liner was attempted with the same results.Screws were re-tightened and a shorter screw was implanted, however this did not correct the issue.Lastly, a third liner was opened and cemented into place to complete the procedure.There was an hour delay as a result.No further patient complications were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.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: IT XLPE 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: 7490890
• MDR Text Key: 107494671
• Report Number: 0001822565-2018-02437
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK151448
• 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: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 00875201836
• Device Lot Number: 63235047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2016
• 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