MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 32MM I.D. SIZE E NEUTRAL LINER; PROSTHESIS, HIP

Catalog Number	30103205
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: japan.Visual examination of the returned product identified multiple barb tabs to be flattened around the radius of the liner.One barb tab is scraped such that a poly strand protrudes from the liner.Gouging is present on the sidewall.One light scratch was observed on the outer radius of the liner.Complaint confirmed based on evaluation of returned product.Review of the device history record(s) identified no deviations or anomalies during manufacturing.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.This report was originally reported under the wrong manufacturer: (b)(4) biomet.
Event or Problem Description
It was reported that during the procedure, the surgeon was not able to assemble the lineliner with the shell.Another liner was used to complete the procedure.There was no harm or health consequences to the patient.Attempts have been made and no further information is available.

• Brand Name: 32MM I.D. SIZE E NEUTRAL LINER
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17941131
• Report Number: 0001822565-2023-02851
• Device Sequence Number: 6416375
• Product Code: LPH
• UDI-Device Identifier: 00889024519855
• UDI-Public: (01)00889024519855(17)240930(10)64531603
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K190660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/16/2023

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: 09/30/2024
• Device Catalogue Number: 30103205
• Device Lot Number: 64531603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK SHELL
• Patient Sex: Unknown