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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EPOLY 36MM RLC LNR MROM SZ28 PROSTHESIS, HIP

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ZIMMER BIOMET, INC. EPOLY 36MM RLC LNR MROM SZ28 PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Joint Dislocation (2374)
Event Date 11/22/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Foreign: country: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-03702.
 
Event Description
It was reported the patient underwent a right hip revision approximately 1year post implantation due to dislocation. No additional information.
 
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Brand NameEPOLY 36MM RLC LNR MROM SZ28
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 Key13112002
MDR Text Key283401293
Report Number0001825034-2021-03508
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K100048
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/25/2020
Device Model NumberN/A
Device Catalogue NumberEP-105996
Device Lot Number519460
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/16/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/25/2015
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: 12/29/2021 Patient Sequence Number: 1
Treatment
CAT#00801803601 FEMORAL HEAD LOT#64210593
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