MAUDE Adverse Event Report: ZIMMER BIOMET, INC. XLPE 10 DEG POLY LINER 46X28; PROSTHETIC, HIP

Model Number N/A

Device Problems Difficult to Insert (1316); Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/19/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (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 during the procedure, the surgeon successfully implanted the 46mm trilogy acetabular cup, and the conventional technique was used to implant the polyethylene pad 46*28mm.However, it was found that the cup clasp could not move normally after implantation of the gasket.When the liner was taken out and examined on the back of the liner, a small amount of irregular polyethylene protrusions were found at the lower part of the mortar.A new liner was used to completed the procedure attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 0002648920-2021-00117.

Event Description

Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number: 0002648920-2021-00117.

• Brand Name: XLPE 10 DEG POLY LINER 46X28
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11273600
• MDR Text Key: 230110584
• Report Number: 0001822565-2021-00275
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024124622
• UDI-Public: 00889024124622
• Combination Product (y/n): N
• PMA/PMN Number: K990135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 00631004628
• Device Lot Number: 64369114
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Weight: 55