Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM 7MM MINI MINI; SHOULDER, PROSTHESIS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER BIOMET, INC. COMP PRIMARY STEM 7MM MINI MINI; SHOULDER, PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Positioning Failure (1158)
Patient Problem No Information (3190)
Event Date 09/14/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).Foreign: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 product did not have a tight press fit.A different implant was used to complete the procedure.
 
Manufacturer Narrative
Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
Event Description
No further event information available at the time of this report.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
COMP PRIMARY STEM 7MM MINI MINI
Type of Device
SHOULDER, PROSTHESIS
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key10648978
MDR Text Key210432573
Report Number0001825034-2020-03749
Device Sequence Number1
Product Code HSD
Combination Product (y/n)N
PMA/PMN Number
K060692
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number113627
Device Lot Number660580
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-