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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E-POLY 36MM +3 HIWALL LNR SZ23 PROSTHESIS, HIP

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ZIMMER BIOMET, INC. E-POLY 36MM +3 HIWALL LNR SZ23 PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Fracture (1260); Unstable (1667); Device Dislodged or Dislocated (2923)
Patient Problems Failure of Implant (1924); Joint Dislocation (2374)
Event Date 11/23/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device will not be returned for analysis, as the device was requested but not returned hospital; however, an investigation of the reported event is in progress. 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: 0001825034-2022-00409.
 
Event Description
It was reported that the patient underwent a revision procedure approximately 4 years post implantation due to fracture of the poly liner after a dislocation event causing the hip to become unstable. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameE-POLY 36MM +3 HIWALL LNR SZ23
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 Key13618195
MDR Text Key286233809
Report Number0001825034-2022-00408
Device Sequence Number1
Product Code MAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090103
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/17/2022
Device Model NumberN/A
Device Catalogue NumberEP-108323
Device Lot Number397790
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/17/2017
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: 02/28/2022 Patient Sequence Number: 1
Treatment
CAT#: 11-363665 COCR HEAD LOT#: 651780
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