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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LT OFFSET RASP HNDL ML TAPER; HIP PROSTHESIS
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ZIMMER BIOMET, INC. LT OFFSET RASP HNDL ML TAPER; HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Difficult to Insert (1316)
Patient Problem No Patient Involvement (2645)
Event Date 02/22/2019
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
It was reported that prior to surgery/during kit inspection a loose rasp-handle was discovered.The rasp can not be fixed anymore.There was no patient involvement.Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
Upon reassessment of the reported event, it was determined to be not reportable.No serious injury has previously been reported due to this malfunction therefore the initial report was forwarded in error and should be voided.
 
Event Description
Upon reassessment of the reported event, it was determined to be not reportable.No serious injury has previously been reported due to this malfunction therefore the initial report was forwarded in error and should be voided.
 
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Brand Name
LT OFFSET RASP HNDL ML TAPER
Type of Device
HIP PROSTHESIS
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8437183
MDR Text Key139348439
Report Number0001822565-2019-01145
Device Sequence Number1
Product Code LXH
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number00771203501
Device Lot Number62503607
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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