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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN PROXIMAL SCREW PROSTHESIS TRAUMA

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ZIMMER BIOMET, INC. UNKNOWN PROXIMAL SCREW PROSTHESIS TRAUMA Back to Search Results
Model Number N/A
Device Problem Unintended Movement (3026)
Patient Problems Pain (1994); Unspecified Tissue Injury (4559)
Event Date 03/13/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Source: uk. The customer has not indicated whether the product will be returned to zimmer biomet for investigation or not. Once this information is obtained a follow-up mdr will be submitted.
 
Event Description
It was reported through a study that a patient had soft tissue irritation and underwent reoperation for proximal screws removal approximately 1 year post implantation. Attempts have been made and there is no further information at this time.
 
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Brand NameUNKNOWN PROXIMAL SCREW
Type of DevicePROSTHESIS TRAUMA
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
p.o. box 587
warsaw IN 46581
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
p.o. box 587
warsaw IN 46581
Manufacturer Contact
jennifer rapsavage
56 e. bell dr.
warsaw, IN 46582
5745260384
MDR Report Key15058945
MDR Text Key296210808
Report Number0001825034-2022-01678
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Health Professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/29/2022
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: 07/19/2022 Patient Sequence Number: 1
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