MAUDE Adverse Event Report: BIOMET UK LTD. G7 ACETABULAR CUP SYSTEM - CERAMIC ACETABULAR LINER; HIP PROSTHESIS

Model Number N/A

Device Problem Unsealed Device Packaging (1444)

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

Event Date 03/25/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4) g2 ¿ foreign ¿ china investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that there was no seal on the sterile package containing a ceramic acetabular liner.This event is related to a malfunction that could potentially lead to a sterility issue/serious injury.However, no patient harm or further outcome was reported.Due diligence is in progress for this complaint; to date no additional information or product has been received.

• Brand Name: G7 ACETABULAR CUP SYSTEM - CERAMIC ACETABULAR LINER
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 19151009
• MDR Text Key: 340675824
• Report Number: 3002806535-2024-00152
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00887868271144
• UDI-Public: (01)00887868271144(17)331026(10)3176673
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 110003634
• Device Lot Number: 3176673
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/26/2023
• 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