MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LONGEVITY HIGHLY CROSSLINKED POLYETHYLENE 32MM I.D. SIZE II ELEVATED RIM LINER; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/02/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).G2: foreign ¿ canada.The 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 surgery, the liner could not be placed in the cup.A new liner was used to complete the procedure.There was no known impact or consequences to the patient.It was reported that no further information is available.

• Brand Name: LONGEVITY HIGHLY CROSSLINKED POLYETHYLENE 32MM I.D. SIZE II ELEVATED RIM LINER
• Type of Device: 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: 19165833
• MDR Text Key: 340876839
• Report Number: 0001822565-2024-01375
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00889024149717
• UDI-Public: (01)00889024149717(17)281010(10)66258085
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K200823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00875201032
• Device Lot Number: 66258085
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1