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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM BEADED FULLCOAT COLLARED 12/14; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. FEMORAL STEM BEADED FULLCOAT COLLARED 12/14; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Tear, Rip or Hole in Device Packaging (2385)
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
Device was returned with packaging damage, and sterility barrier is 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
FEMORAL STEM BEADED FULLCOAT COLLARED 12/14
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key10983732
MDR Text Key220677040
Report Number0001822565-2020-04066
Device Sequence Number1
Product Code LPH
UDI-Device Identifier00889024136915
UDI-Public(01)00889024136915
Combination Product (y/n)N
PMA/PMN Number
K953337
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 12/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number00784301736
Device Lot Number63826199
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2020
Was the Report Sent to FDA? No
Date Manufacturer Received12/31/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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