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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN STEM PROSTHESIS, HIP

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ZIMMER BIOMET, INC. UNKNOWN STEM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Corroded (1131)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical devices: 00801804003 femoral head 61123356; 00630506040 liner 61154845; item #: unknown, unknown cup lot #: unknown. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 03800, 0002648920 - 2021 - 00007. Complaint sample was evaluated and the reported event was confirmed. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. Root cause was unable to be determined. Visual evaluation of the head identified the following: there was abundant corrosion debris in the taper. If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Event Description
It was reported patient underwent hip revision on an unknown date due to unknown reasons. Head and liner components were removed and replaced. Upon examination of returned devices, the liner has been determined to have fractured and the head shows signs of wear and corrosion. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameUNKNOWN STEM
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 Key11146914
MDR Text Key226019216
Report Number0001822565-2021-00107
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 01/11/2021 Patient Sequence Number: 1
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