MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 NEUTRAL ARCOMXL LINER 32MM F; PROSTHESIS, HIP

Model Number N/A

Device Problem Packaging Problem (3007)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/08/2015

Event Type  malfunction  

Manufacturer Narrative

An investigation into this issue is ongoing and when additional information is received, a follow-up report will be submitted to the fda.

Event Description

It was reported that patient underwent a total hip arthroplasty on (b)(6) 2015.After implantation of the acetabular liner, the surgeon realized a hi-wall acetabular liner was implanted, not a neutral acetabular liner as described on the packaging label.The surgeon decided the hi-wall liner fit well and left it implanted.

Manufacturer Narrative

Examination of returned device found evidence of product non-conformance.Corrective action has been initiated to address the reported issue.

• Brand Name: G7 NEUTRAL ARCOMXL LINER 32MM 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: 5029363
• MDR Text Key: 24814191
• Report Number: 0001825034-2015-03767
• 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
• Remedial Action: Other
• Type of Report: Followup
• Report Date: 09/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/11/2019
• Device Model Number: N/A
• Device Catalogue Number: 010000733
• Device Lot Number: 3423976
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2014
• 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): Other