MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 ACETABULAR SHELL 3 HOLE POROUS PLASMA, CEMENTLESS 48 MM C; PROSTHESIS, HIP

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Hip Fracture (2349)

Event Date 08/09/2016

Event Type  Injury  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 4 states, "loosening, migration, or fracture of the implants can occur due to loss of fixation, trauma, malalignment, malposition, non-union, bone resorption, and/or excessive, unusual and/or awkward movement and/or activity." number 14 states, "postoperative bone fracture and pain.' this report is number 2 of 4 mdrs filed for the same event (reference 9613350-2016-01189 & 1825034-2016-03621 / 03622 / 03623).

Event Description

Patient underwent a hip revision procedure approximately five months post-implantation due to cup migration, screw fracture, and acetabular fracture.The modular head, hip bearing, cup, and screws were removed and replaced.An acetabular buttress was also implanted.

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

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

Event Description

Patient underwent a hip revision procedure approximately five months post-implantation due to cup migration, screw fracture, and acetabular fracture.It was further reported in operative notes received that clear yellow effusion, granulomatous type synovitis, scar tissue, pseudoacetabulum, and heterotopic bone were noted.One screw was found to be broken and another had pulled out of the bone.A piece of the fractured screw was retained by the patient.The modular head, hip bearing, cup, and screws were removed and replaced.An acetabular buttress was also implanted.

Manufacturer Narrative

Catalog 010000661 lot 3675020.(b)(4).

• Brand Name: G7 ACETABULAR SHELL 3 HOLE POROUS PLASMA, CEMENTLESS 48 MM C
• 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: 5950320
• MDR Text Key: 54697147
• Report Number: 0001825034-2016-03621
• 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,Followup,Followup
• Report Date: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000661
• Device Lot Number: 3675020
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2015
• 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: 62 YR