MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 NEUTRAL ARCOMXL LNR 36MM F; PROSTHESIS, HIP

Model Number N/A

Device Problem Accessory Incompatible (1004)

Patient Problem No Information (3190)

Event Date 12/08/2015

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.Examination of returned device found no evidence of product non-conformance.Review of the device confirmed the reported condition.During the evaluation, deformation of the device was noted.A conclusive root cause of the event could not be determined.Corrective action has been initiated to address the reported issue.This report is number 1 of 2 mdr's filed for the same patient (reference 1825034-2016-02202 / 02203).

Event Description

It was reported that during a hip arthroplasty, two poly liners would no seat into the cup.Two screws were removed from the cup, and a third liner was used.The third liner would not initially seat.The dome plug was removed from the cup, and the third liner was used to complete the procedure.A thirty minute delay in procedure occurred.

• Brand Name: G7 NEUTRAL ARCOMXL LNR 36MM F
• 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: 5741076
• MDR Text Key: 47903076
• Report Number: 0001825034-2016-02202
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 010000741
• Device Lot Number: 3585216
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2015
• 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): Other; Required Intervention