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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DIST TIB MEDIAL RT 15H PROSTHESIS TRAUMA

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ZIMMER BIOMET, INC. DIST TIB MEDIAL RT 15H PROSTHESIS TRAUMA Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem Failure of Implant (1924)
Event Date 07/19/2021
Event Type  Injury  
Manufacturer Narrative

(b)(4). Report source - (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Revision hasn't occured yet.

 
Event Description

It was reported that the plate broke after 3 months of recuperation. The patient did not fall or did any thing that was not recommended. It was reported that the patient was diabetic and was recuperating well. The patient will be re-operated to fix the issue. There was no injury to the patient, body or health. Attempts have been made and there is no further information at this time.

 
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Brand NameDIST TIB MEDIAL RT 15H
Type of DevicePROSTHESIS TRAUMA
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 Key12307085
MDR Text Key266003567
Report Number0001825034-2021-02359
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK072832
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/15/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/11/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number816210015
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 Received08/20/2021
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: 08/11/2021 Patient Sequence Number: 1
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