MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 6.5MM X 45MM SCREW; PROSTHESIS, HIP

Model Number N/A

Device Problems Device Slipped (1584); Material Integrity Problem (2978); Positioning Problem (3009)

Patient Problems Fall (1848); Test Result (2695)

Event Date 05/29/2015

Event Type  Injury  

Event Description

It was reported that patient underwent an initial total hip arthroplasty on (b)(6) 2015.Subsequently, patient was revised on (b)(6) 2015 due to a screw head being elevated, a malpositioned cup, and loosening of the ceramic liner after a patient fall.The modular head, acetabular cup, liner and screws were removed and replaced.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.The identification of the screw that backed out cannot be determined at this time.It may have been the screw reported on this medwatch or the screw associated with manufacturer report number 1825034-2015-02695.Expiration date - unknown; manufacture date ¿ unknown.This report is number 3 of 4 mdrs filed for the same event (reference 1825034-2015-02692 / 02695).

Manufacturer Narrative

The follow-up report is being filed to relay additional information that 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.

Manufacturer Narrative

Product left conforming to print as there was no evidence that states otherwise.From the investigation we can conclude that the failure of the implant is due to the liner not being seated correctly and the use of an apical plug which is only to be used with polythene liners.The failure mode is surgical technique.However, the surgical technique has been updated to reflect that care must be taken not to fit a apical plug with a ceramic liner.Based on these results the complaint is considered confirmed.

• Brand Name: G7 6.5MM X 45MM SCREW
• 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: 4870983
• MDR Text Key: 6045524
• Report Number: 0001825034-2015-02694
• 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: Foreign,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/23/2015

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 Model Number: N/A
• Device Catalogue Number: 010001002
• Device Lot Number: 3473071
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/02/2015
• Initial Date FDA Received: 06/26/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/08/2015; 11/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2014
• 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: 112