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. MINI HUMERAL TRAY; PROSTHESIS, SHOULDER
  • 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. MINI HUMERAL TRAY; PROSTHESIS, SHOULDER Back to Search Results
Model Number N/A
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Joint Dislocation (2374)
Event Date 10/23/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.Concomitant medical products: item number: 110031422, item name: humeral bearing, lot number: 64361197, item number: unknown, item name: unknown glenosphere, lot number: unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-04043, 0001825034-2020-04044.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported patient underwent a left shoulder revision surgery approximately two months post-implantation due to dislocation.During surgery it was discovered that the poly insert was free floating, and no longer attached to the tray.The tray and liner components were removed and replaced.Attempts have been made and no additional information is available at this time.
 
Manufacturer Narrative
(b)(4).D11: item number: 110030777, item name: versa-dial glenosphere, lot number: 64416224.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 1822565.
 
Event Description
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 1822565.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MINI HUMERAL TRAY
Type of Device
PROSTHESIS, SHOULDER
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key10817954
MDR Text Key215570546
Report Number0001825034-2020-04042
Device Sequence Number1
Product Code PAO
Combination Product (y/n)N
PMA/PMN Number
K181611
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup,Followup
Report Date 03/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number110031400
Device Lot Number64691513
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2020
Was the Report Sent to FDA? No
Date Manufacturer Received03/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age68 YR
-
-