MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 NEUTRAL E1 LINER 36MM E; PROSTHESIS, HIP

Model Number N/A

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2016

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under warnings, number 2 states, "prior to seating the liner into the shell component, all surgical debris (tissue fragments, etc.) must be removed from the interior of the shell component, as debris may inhibit the locking mechanism from engaging and securing the liner into the shell component.".

Event Description

During a hip arthroplasty the acetabular liner did not seat properly into the acetabular cup.Another acetabular liner was used to complete the procedure with minimal delay and no patient injury.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.(b)(4).

• Brand Name: G7 NEUTRAL E1 LINER 36MM E
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5778545
• MDR Text Key: 49050489
• Report Number: 0001825034-2016-02532
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 010000857
• Device Lot Number: 3464295
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 66