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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. #7 PE ZIPLOOP EXT TOGGLELOC PROSTHESIS, SPORTSMED

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ZIMMER BIOMET, INC. #7 PE ZIPLOOP EXT TOGGLELOC PROSTHESIS, SPORTSMED Back to Search Results
Model Number N/A
Device Problem Fracture
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Foreign: event occurred in (b)(6). Reported event was unable to be confirmed due to limited information received from the customer. Device history record was reviewed and no discrepancies were found. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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.

 
Event Description

It was reported that the wire of the ziploop toggleloc fractured. Attempts have been made and additional information on the reported event is unavailable at this time. No adverse events have been reported as a result of the malfunction.

 
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Brand Name#7 PE ZIPLOOP EXT TOGGLELOC
Type of DevicePROSTHESIS, SPORTSMED
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 Key9239163
Report Number0001825034-2019-04845
Device Sequence Number1
Product CodeHSN
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation PHARMACIST
Type of Report Initial,Followup
Report Date 06/04/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/25/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number904755
Device LOT NumberP07854
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/10/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/03/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/13/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction NumberN/A

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