MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET E-POLY LINER; HIP PROSTHESIS

Model Number N/A

Device Problem Naturally Worn (2988)

Patient Problem No Information (3190)

Event Date 12/22/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was requested, but not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: item # 11-363660, femoral head, lot # 641190, item # 12-104158, shell, lot # 972760, item # hips-unknown-stems-unk, lot # unk.(b)(6).

Event Description

It was reported that the patient underwent a revision surgery approximately 6 years post implantation due to poly liner wear.Attempts have been made, and no further information has been provided.

Manufacturer Narrative

This follow up report is being submitted to report additional information.Reported event was confirmed through photographs received.Photographs of the explanted head and liner were provided.The liner is completely worn and fractured into multiple pieces and scratches were noted on explanted cocr head outer surface.However, no further evaluation can be performed based using the photographs provided and dimensional evaluations could not be performed since the product is not returned.Device history record (dhr) was reviewed and no discrepancies were found.Review of complaint history determined that no further action is required.Root cause was unable to be determined.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: BIOMET E-POLY LINER
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7351256
• MDR Text Key: 102839040
• Report Number: 0001825034-2018-01842
• Device Sequence Number: 1
• Product Code: MAY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK090103
• 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
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/28/2015
• Device Model Number: N/A
• Device Catalogue Number: EP-108323
• Device Lot Number: 155640
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2010
• 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