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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN INSTRUMENT SCREW, FIXATION

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ZIMMER BIOMET, INC. UNKNOWN INSTRUMENT SCREW, FIXATION Back to Search Results
Catalog Number SEE H10 NARRATIVE
Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 02/27/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Report source: foreign: (b)(6). It is unknown if product will be returning to zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up report will be submitted.
 
Event Description
It was reported that the patient underwent a revision procedure due to pain. It was further indicated that the instrumentation was related to the revision.
 
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Brand NameUNKNOWN INSTRUMENT
Type of DeviceSCREW, FIXATION
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 Key11752813
MDR Text Key248391963
Report Number0001825034-2021-01327
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K063570
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberSEE H10 NARRATIVE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/30/2021 Patient Sequence Number: 1
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