MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 PPS LTD ACET SHELL 54F; PROSTHESIS, HIP

Model Number N/A

Device Problems Fracture (1260); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Fall (1848); No Information (3190)

Event Date 12/20/2015

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 warnings, it states, ¿improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components.¿ this report is number 3 of 3 mdr's filed for the same event (reference 1825034-2016-00152 / 00153 and 00154).

Event Description

It was reported that patient underwent left total hip arthroplasty on (b)(6) 2015 and right total hip arthroplasty on (b)(6) 2015.During the right hip procedure, the cup was removed upon implantation due to a sizing issue.A second cup was used to complete the procedure.Subsequently, patient underwent a right revision procedure on (b)(6) 2015 due to a fall, which fractured the right acetabulum.All components were removed and replaced, and the cause of the fall is unknown.Subsequently, patient experienced a second fall and sustained a periprosthetic left femoral fracture.Patient underwent a left hip revision procedure on (b)(6) 2015 due to the fracture.The femoral component and head were removed and replaced, and the fracture was reduced with cables.

Manufacturer Narrative

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

• Brand Name: G7 PPS LTD ACET SHELL 54F
• 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: 5366890
• MDR Text Key: 35962734
• Report Number: 0001825034-2016-00154
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 010000664
• Device Lot Number: 3616428
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2015
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR