MAUDE Adverse Event Report: BIOMET ORTHOPEDICS 28MM X 50MM E1 RINGLOC BIPOLAR ACETABULAR CUP; PROSTHESIS, HIP

Model Number N/A

Device Problem Component or Accessory Incompatibility (2897)

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

Event Date 04/07/2016

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly or deviation.This report is number 4 of 4 mdrs filed for the same patient (reference 3002806535-2016-00221, 3002806535-2016-00762, 1825034-2016-03413, 1825034-2016-03785).

Event Description

During a bipolar hip arthroplasty, on the second attempted modular head used, the surgeon felt the ceramic head had restricted movement within the bipolar cup but implanted the components.

• Brand Name: 28MM X 50MM E1 RINGLOC BIPOLAR ACETABULAR CUP
• 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: 5975143
• MDR Text Key: 55562622
• Report Number: 0001825034-2016-03785
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 110010470
• Device Lot Number: 441070
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2016
• Initial Date FDA Received: 09/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2014
• 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