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

Model Number	N/A
Medical Device Problem Codes	Difficult to Insert (1316); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/19/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem Description
No further event information available at the time of this report.
Additional 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 or Problem 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
• Common Device Name: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11273600
• Report Number: 0001822565-2021-00275
• Device Sequence Number: 3562820
• Product Code: LPH
• UDI-Device Identifier: 00889024124622
• UDI-Public: 00889024124622
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K990135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 02/19/2021; 05/11/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 02/22/2021; 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Weight: 55