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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN HEAD PROSTHETIC, HIP

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ZIMMER BIOMET, INC. UNKNOWN HEAD PROSTHETIC, HIP Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems No Information (3190); Insufficient Information (4580)
Event Date 01/22/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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 - 00396.
 
Event Description
It was reported by the 411 group the patient underwent an initial total hip arthroplasty on an unknown date. Subsequently the patient has been indicated for a revision, however, a revision has not been reported. The sales rep was inquiring about implant identification for a liner and head exchange. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameUNKNOWN HEAD
Type of DevicePROSTHETIC, 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 Key11293441
MDR Text Key230725977
Report Number0001825034-2021-00395
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 distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 05/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received05/25/2021
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: 02/08/2021 Patient Sequence Number: 1
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