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

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VGXP XP E1 TIB BRG RM 9X71 PROSTHESIS, 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
 

ZIMMER BIOMET, INC. VGXP XP E1 TIB BRG RM 9X71 PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Pain (1994); Swelling (2091)
Event Date 12/24/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). Multiple mdr reports were filed for this event, please see associated report: 0001825034-2021-00071. Concomitant medical products: vgxp xp e1 tib brg rl 9x71, item# 195779, lot# 691500. Vgxp xp inlk pri tib tray 71mm, item# 195755, lot# 780210. Vgxp intlk femoral rt 65, item# 195910, lot# 378420. Report source - (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported that a patient was revised approximately five years and five weeks post implantation due to pain, swelling, and loosening of the articular surfaces. After the initial surgery, the patient experienced pain and swelling on his knee and went to see a doctor. Surface loosening was confirmed by the diagnosis. A revision was performed to replace the surfaces with thicker ones. There is no additional information at this time.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVGXP XP E1 TIB BRG RM 9X71
Type of DevicePROSTHESIS, KNEE
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 Key11163482
MDR Text Key226571661
Report Number0001825034-2021-00070
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK132873
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/10/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/13/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/28/2020
Device MODEL NumberN/A
Device Catalogue Number195849
Device LOT Number701780
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/04/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/28/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 01/13/2021 Patient Sequence Number: 1
-
-