• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VANGUARD XP TIBIAL LOCKING BAR 59-67 PROTHESIS, KNEE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOMET ORTHOPEDICS VANGUARD XP TIBIAL LOCKING BAR 59-67 PROTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Difficult To Position (1467)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/26/2016
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: vanguard xp- xp e1 tibal bearing right lateral 9x63, item number: 195772, lot number: 476480. This report is number 1 of 2 mdrs filed for the same patient (reference 0001825034-2017-00456).

 
Event Description

It was reported the bearing would not sit flush in the tibial tray.

 
Manufacturer Narrative

This follow-up report is being submitted to relay additional information. Medical product: item name: vgxp xp e1 tib brg rl 9x63, catalog number: 195772, lot number: 476480, item name: series a 3 peg std 34x8. 5, catalog number: 184766, lot number: 127830, item name: vgxp xp med tib brg rt 9x63, catalog number: 195842, lot number: 869200, item name: vang xp inlk femoral rt 65, catalog number: 195910, lot number: 729560, item name: vang xp inlk pri tib tray 67mm, catalog number: 195753, lot number: 906680.

 
Manufacturer Narrative

This follow-up report is being submitted to relay additional information. 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. Review of the complaint history determined that no further action is required as no were trends identified. The components were reviewed for compatibility with no issues noted. Root cause was unable to be determined. A summary of the investigation will be 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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVANGUARD XP TIBIAL LOCKING BAR 59-67
Type of DevicePROTHESIS, KNEE
Manufacturer (Section D)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6312690
MDR Text Key66863367
Report Number0001825034-2017-00457
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberPK132873
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/31/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/08/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number195762-00
Device LOT Number325320
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/21/2014
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

-
-