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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ACROM XL 44-41 STD +3 HMRL BRG; PROSTHESIS, SHOULDER
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ZIMMER BIOMET, INC. ACROM XL 44-41 STD +3 HMRL BRG; PROSTHESIS, SHOULDER Back to Search Results
Model Number N/A
Device Problem Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
Returned goods classification code vc, packaging damage with sterility barrier potentially compromised.
 
Manufacturer Narrative
Upon reassessment of the reported event, it was determined to be not reportable as sterility was not breached.The initial report was forwarded in error and should be voided.
 
Event Description
No further event information available at the time of this report.
 
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Brand Name
ACROM XL 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 Key10188337
MDR Text Key196232097
Report Number0001825034-2020-02472
Device Sequence Number1
Product Code KWS
UDI-Device Identifier00880304475823
UDI-Public(01)00880304475823
Combination Product (y/n)N
PMA/PMN Number
K080642
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 09/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/27/2023
Device Model NumberN/A
Device Catalogue NumberXL-115367
Device Lot Number915700
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/05/2020
Was the Report Sent to FDA? No
Date Manufacturer Received09/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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