• 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. OXFORD CEMENTLESS TIBIA B RM; 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. OXFORD CEMENTLESS TIBIA B RM; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/13/2015
Event Type  malfunction  
Manufacturer Narrative
Zimmer biomet complaint (b)(4).Complaint sample was evaluated and the reported event was confirmed."we can conclude from the investigation that the implant was correct to packaging protocol, and conforming.The inner package being tear is mostly likely due to inappropriate handling and shipping operations."review of device history records found these units were released to distribution with no deviations or anomalies.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 implant's inner sterile packaging was not sealed and the implant fell onto the floor in the sterile field.Since there was a tear in the packaging, the surgeon did not feel comfortable using it and another implant was used to complete the procedure without delay.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
OXFORD CEMENTLESS TIBIA B RM
Type of Device
PROSTHESIS, 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 Key6932423
MDR Text Key89955485
Report Number0001825034-2017-08283
Device Sequence Number1
Product Code NRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PNOT LISTED
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 10/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2023
Device Model NumberN/A
Device Catalogue NumberUS166573
Device Lot Number3050465
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/10/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/13/2015
Initial Date FDA Received10/09/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/20/2013
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
Patient Sequence Number1
Patient Age70 YR
-
-