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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E1 44-41 STD HMRL BRNG; PROSTHESIS, SHOULDER
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ZIMMER BIOMET, INC. E1 44-41 STD HMRL BRNG; PROSTHESIS, SHOULDER Back to Search Results
Catalog Number EP-115396
Device Problem Insufficient Information (3190)
Patient Problems Hematoma (1884); Unspecified Infection (1930)
Event Date 12/29/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products: 115320, comp rvrs shldr glnsp std 41mm, 982860.110032410, comp aug mini bsplt w tpr sm, 64027393.115370, comp rvs tray co 44mm, 430240.113631, comp primary stem 11mm mini, 429670.180553, comp lk scr 3.5hex 4.75x30 st, 641770.180553, comp lk scr 3.5hex 4.75x30 st, 237980.180551, comp lk scr 3.5hex 4.75x20 st, 482230.180550, comp lk scr 3.5hex 4.75x15 st, 777050.115395, comp rvs cntrl 6.5x25mm st/rst, 837870.Report source: foreign- (b)(6).The complaint is under investigation.Once the investigation is completed a follow up report will be submitted.Multiple mdr reports were filed for this event; please see associated reports: 0001825034-2019-00213, 0001825034-2019-00214, 0001825034-2019-00215.
 
Event Description
It was reported that the patient underwent an initial reverse shoulder arthroplasty and underwent a revision due to hematoma approximately one month post implantation.No additional information is available at this time.
 
Event Description
It was reported that the patient underwent an initial reverse shoulder arthroplasty and underwent a revision due to infection approximately one month post implantation.Patient experienced hematoma post primary surgery no additional information is available at this time.
 
Manufacturer Narrative
Udi: (b)(4).The complaint cannot be confirmed as the medical records were not provided.Dhr was reviewed and no discrepancies were found.A definite root cause cannot be determined with the information 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.
 
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Brand Name
E1 44-41 STD HMRL BRNG
Type of Device
PROSTHESIS, SHOULDER
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8292709
MDR Text Key134595146
Report Number0001825034-2019-00405
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 distributor,foreign,health pr
Type of Report Initial,Followup
Report Date 03/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/09/2023
Device Catalogue NumberEP-115396
Device Lot Number512120
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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