MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 SCREW 6.5MM X 35MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Malposition of Device (2616); Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 05/14/2015

Event Type  Injury  

Event Description

It was reported that patient underwent an initial total hip arthroplasty on (b)(6) 2015.During the procedure, the screw would not seat into the acetabular cup causing the screw to strip.Two different screws were attempted and the hole was re-drilled but were unsuccessful.The procedure was completed without implanting a screw.

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 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." evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be sent to the fda.This report is number 1 of 3 mdrs filed for the same event (reference 1825034-2015-02536 / 02538).

Manufacturer Narrative

Examination of returned device found no evidence of product non-conformance.Evaluation of device found evidence that failure mode was most likely due to misalignment when drilling or positioning the g7 shell.

• Brand Name: G7 SCREW 6.5MM X 35MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; waterton industrial estate; bridgend, south wales
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 4838073
• MDR Text Key: 5914795
• Report Number: 0001825034-2015-02536
• Device Sequence Number: 1
• Product Code: JDI
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 010001000
• Device Lot Number: 3326393
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/15/2015
• Initial Date FDA Received: 06/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2014
• 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 Weight: 102