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

Model Number N/A

Device Problem Packaging Problem (3007)

Patient Problem No Information (3190)

Event Date 01/09/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).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.

Event Description

It was reported that during a hip surgery, a hair was found with the liner in the box.Surgery was completed with another device.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product prior to decontamination could not confirm the reported issue.No hair was found at the time of arrival.The original packaging content was not returned with the device.Dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot 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.

Event Description

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

• Brand Name: IT XLPE LINERS
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8370420
• MDR Text Key: 137316682
• Report Number: 0001822565-2019-00900
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K151448
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00875201432
• Device Lot Number: 63915192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR