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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE MINI HUMERAL STEM, SIZE 8 PROSTHESIS, SHOULDER

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ZIMMER BIOMET, INC. COMPREHENSIVE MINI HUMERAL STEM, SIZE 8 PROSTHESIS, SHOULDER Back to Search Results
Model Number N/A
Device Problems Difficult to Insert (1316); Inadequacy of Device Shape and/or Size (1583)
Patient Problem Infiltration into Tissue (1931)
Event Date 06/06/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products: unknown broach, unk. Report source: (b)(6). Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-02857. Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported that after preparing the humeral canal with a size 9 broach, the size 8 mini stem was selected for implantation, as there is a 1. 5mm press-fit. Stem was introduced, and had absolutely no press-fit. The size 8 mini stem was removed. The procedure was completed by rasping lightly to size 10, and inserting a size 9 mini stem. Attempts have been made to gain information, however no additional information was made available.

 
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Brand NameCOMPREHENSIVE MINI HUMERAL STEM, SIZE 8
Type of DevicePROSTHESIS, SHOULDER
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 Key8750993
MDR Text Key149759635
Report Number0001825034-2019-02795
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK183550
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/25/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/01/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number113628
Device LOT Number902250
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/11/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/24/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/01/2017
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: 07/01/2019 Patient Sequence Number: 1
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