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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VISION RINGLOC SHELL 50MM SZ23 PROSTHESIS, HIP

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ZIMMER BIOMET, INC. VISION RINGLOC SHELL 50MM SZ23 PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Component Missing
Event Date 04/28/2015
Event Type  Malfunction  
Manufacturer Narrative

Zimmer biomet complaint- complaint sample was evaluated and the reported event was confirmed. The evaluation is being addressed in an internal health hazard evaluation. Dhr was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required as no were trends identified. Root cause was unable to be determined. A summary of the investigation has been sent to the complainant. 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.

 
Event Description

It was reported that the screw hole plugs were not in the screw holes on the vision ringloc cup or in the packaging. The surgeon used the cup to complete the procedure without the screw hole plugs. No adverse event occurred. Another cup with the same part and lot was also found in inventory at zimmer biomet (b)(4) with the same issue.

 
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Brand NameVISION RINGLOC SHELL 50MM SZ23
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw , IN 46582
5745273773
MDR Report Key6958111
Report Number0001825034-2017-09055
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 10/18/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/18/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number135250
Device LOT Number946410
OTHER Device ID NumberN/A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/19/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/28/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/28/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

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