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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. TIBIAL RESEC HEAD-LEFT W/ALIG KNEE PROSTHESIS

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BIOMET UK LTD. TIBIAL RESEC HEAD-LEFT W/ALIG KNEE PROSTHESIS Back to Search Results
Model Number N/A
Device Problems Defective Device (2588); Appropriate Term/Code Not Available (3191)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 08/06/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The investigation is in process. Once the investigation is complete, a follow-up mdr will be submitted.
 
Event Description
It was reported that the left vanguard tibial cut block would not thread onto tibial resection guide. It was determined that it was the cut block that was the issue as the right block threaded on just fine.
 
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Brand NameTIBIAL RESEC HEAD-LEFT W/ALIG
Type of DeviceKNEE PROSTHESIS
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK CF31 3XA
Manufacturer (Section G)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK CF31 3XA
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key8944149
MDR Text Key156722911
Report Number3002806535-2019-00710
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number32-487556
Device Lot NumberZB151102
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer08/16/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/28/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/02/2015
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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