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. E1 44-41 STD +3 HMRL BRG; 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. E1 44-41 STD +3 HMRL BRG; PROSTHESIS, SHOULDER Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 04/24/2014
Event Type  Injury  
Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Unique identifier (udi) #: n/a.Concomitant medical products: pm555222, herbert pm compr rvs ha bp, lot: 728920; 118001, versa-dial/comp ti std taper, lot: 194470; 113648, comp primary stem 8mm std, lot: 864660; 115323, comp rvsr shldr glnsp +3 41mm, lot: 788010; 115370, comp rvs tray co 44mm, lot: 448500; 115386, comp rvs cntrl scr 6.5x50mm st, lot: 269000; 180554, comp lk scr 3.5hex 4.75x35 st, lot: 729380; 180554, comp lk scr 3.5hex 4.75x35 st, lot: 932440; 180552, comp lk scr 3.5hex 4.75x25 st, lot: 376810; 180556, comp lk scr 3.5hex 4.75x45 st, lot: 620150.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 01170, 0001825034 - 2019 - 01171, 0001825034 - 2019 - 01172, 0001825034 - 2019 - 01173, 0001825034 - 2019 - 01174.
 
Event Description
It was reported that approximately 5 years post implantation, the patient has been indicated for a shoulder revision due to unknown reasons.Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.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
E1 44-41 STD +3 HMRL BRG
Type of Device
PROSTHESIS, SHOULDER
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8421755
MDR Text Key138827268
Report Number0001825034-2019-01176
Device Sequence Number1
Product Code PAO
Combination Product (y/n)N
PMA/PMN Number
K113121
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/30/2018
Device Model NumberN/A
Device Catalogue NumberEP-115397
Device Lot Number230960
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
-
-