MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 SCREW 6.5MM X 25MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Pain (1994); Scar Tissue (2060)

Event Date 09/02/2015

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Three medwatches are being submitted for this event, as it is unknown which screw was found to be fractured.(reference 1825034-02439, 03783 / 03784).This report is number 5 of 6 mdrs filed for the same patient (reference 1825034-2015-02218 / 02219 and 2016-01281, 02439, 03783 / 03784).

Event Description

It was reported patient underwent a right hip revision approximately four months post-implantation due to pain and migration of acetabular component.During the procedure, metallic stained tissue, scar tissue, serous fluid, fractured screw, loose bone fragments, bone damage, tightening of the hip with protrusion and impingement were noted.The modular head, cup and liner were removed and replaced with legacy zimmer product.

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).Medical products - biomet g7 acetabular liner catalog#: 010000867, lot#: 3321534, biomet biolox delta femoral head, catalog#: 650-1058 lot#: 240670, biomet ceramic taper adapter catalog#: 650-1068, lot#: 816410.

• Brand Name: G7 SCREW 6.5MM X 25MM
• 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: 5975140
• MDR Text Key: 55559234
• Report Number: 0001825034-2016-03783
• 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: other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 08/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• 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: 010000998
• Device Lot Number: 3393650
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2014
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR