MAUDE Adverse Event Report: BIOMET ORTHOPEDICS E1 RINGLOC BIPOLAR 28X41MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Bent (1059); Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source - (b)(6).It has been indicated that the device will return for analysis, but it has not yet been received by manufacturer.Once the investigation has been completed, a follow up mdr will be submitted.

Event Description

It was reported that the metal shell ring was damaged before use.Another device was used to complete the procedure without patient injury or significant delay.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection found the ring to be bent with a small portion protruding from the groove in the shell.The chamfer was found to be oriented in the appropriate direction.The ring rotates freely 360 degrees within the shell's groove.The ring was removed from the shell by hand.Dimensional analysis of the ring found the width and height to meet print specifications.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: E1 RINGLOC BIPOLAR 28X41MM
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6622457
• MDR Text Key: 77328044
• Report Number: 0001825034-2017-03634
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK833991
• 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,Followup,Followup
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/29/2021
• Device Model Number: N/A
• Device Catalogue Number: 110010458
• Device Lot Number: 304190
• Other Device ID Number: (01)00880304568747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2016
• 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