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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Necrosis (1971); Pain (1994); Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530); Swelling/ Edema (4577)
Date of Event	09/14/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem 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.
Additional 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.
Event or Problem Description
No further event information available at the time of this report.
Additional 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.

• Brand Name: EPOLY 36MM RLC LNR MROM SZ25
• Common Device Name: 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
• Report Number: 0001825034-2021-03032
• Device Sequence Number: 11902161
• Product Code: OIY
• UDI-Device Identifier: 00880304457461
• UDI-Public: (01)00880304457461(17)200519(10)197310
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K100048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2021
• Supplement Date Received by Manufacturer: 12/16/2021; 01/14/2022
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 12/28/2021; 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White