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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMED ZIMMER BIOMED ACETABULAR TRIAL RING PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL CEMENTED ACETABULAR COMPONENT)

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ZIMMER BIOMED ZIMMER BIOMED ACETABULAR TRIAL RING PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL CEMENTED ACETABULAR COMPONENT) Back to Search Results
Model Number B 31-108425
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/15/2019
Event Type  malfunction  
Event Description
Zimmer biomed acetabular trial c-ring fell off the device. Occurred on two separate occasions, fell into the open operative site. Fda safety report id# (b)(4).
 
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Brand NameZIMMER BIOMED ACETABULAR TRIAL RING
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED (METAL CEMENTED ACETABULAR COMPONENT)
Manufacturer (Section D)
ZIMMER BIOMED
warsaw IN
MDR Report Key8670502
MDR Text Key147095657
Report NumberMW5087100
Device Sequence Number1
Product Code JDL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberB 31-108425
Device Lot Number527930
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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