MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EPOLY 36MM RLC LNR MROM SZ25; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Necrosis (1971); Pain (1994); Ambulation Difficulties (2544); Metal Related Pathology (4530); Swelling/ Edema (4577)

Event Date 09/14/2021

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for analysis location unknown; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 03031, 0001825034 - 2021 - 03033, 0001825034 - 2021 - 03034.

Event Description

It was reported that patient underwent tha on right hip procedure.Patient underwent procedure on four (4) years post implantation to remove a pseudotumor.Subsequently, patient underwent a revision procedure two (2) months later.It was relayed that elevated chromium and cobalt levels were confirmed.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: a4; a5; b7; e1; e2; e3; g3; h2; h3; h6.An investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.

Event Description

Upon reassessment of the reported event, this report should be voided as it was determined to be part of the event reported under mfr number 0001825034-2021-01839.

Manufacturer Narrative

Upon reassessment of the reported event, this report should be voided as it was determined to be part of the event reported under mfr number 0001825034-2021-01839.

• Brand Name: EPOLY 36MM RLC LNR MROM SZ25
• Type of Device: PROSTHESIS, HIP
• 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: 12738766
• MDR Text Key: 279608857
• Report Number: 0001825034-2021-03032
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 00880304457461
• UDI-Public: (01)00880304457461(17)200519(10)197310
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2020
• Device Model Number: N/A
• Device Catalogue Number: EP-105995
• Device Lot Number: 197310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2015
• 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): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White