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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. EPOLY 36MM RLC LNR MROM SZ25 PROSTHESIS, HIP Back to Search Results
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.
 
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Brand NameEPOLY 36MM RLC LNR MROM SZ25
Type of DevicePROSTHESIS, 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 Key12738766
MDR Text Key279608857
Report Number0001825034-2021-03032
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100048
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
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 Received11/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/19/2020
Device Model NumberN/A
Device Catalogue NumberEP-105995
Device Lot Number197310
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/19/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 11/02/2021 Patient Sequence Number: 1
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