MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 STRAIGHT MONOBLOCK ACETABULAR SHELL INSERTER; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/20/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that 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 care and handling of instruments it states, ¿surgical instruments and instrument cases are susceptible to damage for a variety of reasons including prolonged use, misuse, rough or improper handling.¿ this report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.

Event Description

During a total hip arthroplasty, the inserter fractured and part of it fell in the patients wound.The fragment was unable to be removed and remains in the patient.It is unknown if a revision procedure will be performed.This report is based on allegations set forth in plaintiff's complaint, and the allegations contained therein are unverified.

Manufacturer Narrative

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

Manufacturer Narrative

Based on associated device history records, the product was made to print and correct materials.Product left conforming to print as there was no evidence that states otherwise.Visual inspection of the inserter shows the distal threads are fractured.The complaint is therefore confirmed.The fracture pattern of the threads is consistent to that of bending overload.Product most likely failed due to the surgeon leveraging the handle in attempts to reposition the cup and/or from multiple off-centered and angled impactions.It is also possible that the cup began to unthread from the inserter during implantation and was subsequently impacted while loose on the threads causing fracture.It is also possible that the threads were damaged in a previous procedure and failed during this one.However, it is impossible to determine the exact mode of failure as the complaint states the correct surgical technique was used.

Event Description

During a left hip arthroplasty, the inserter fractured during use, and part of it fell in the patients wound.The patient underwent an additional procedure, six days later, to remove a fragment of the inserter.

Manufacturer Narrative

This follow-up report is being filed to relay additional and corrected information, which was unknown at the time of the initial medwatch.Concomitant products: unknown acetabular liner: catalog#: ni, lot#: ni.

• Brand Name: G7 STRAIGHT MONOBLOCK ACETABULAR SHELL INSERTER
• 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: 5890289
• MDR Text Key: 52568786
• Report Number: 0001825034-2016-03182
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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,Followup,Followup
• Report Date: 08/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 110003450
• Device Lot Number: 252060
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 47 YR