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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DEPTH GAUGE PROSTHESIS, HIP

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ZIMMER BIOMET, INC. DEPTH GAUGE PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported the depth gauge broke while the screw size of the acetabulum was being measured. Attempts have been made and no additional information is available at this time.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
Reported event was unable to be confirmed due to limited information received from the customer. The device history records were reviewed and no related deviations/ anomalies were identified that affect the reported event. A definitive 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 NameDEPTH GAUGE
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7946754
MDR Text Key123070983
Report Number0001822565-2018-05610
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
PMA/PMN Number
PEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00661109800
Device Lot Number62079717
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

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