• 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. TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE CD 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. TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE CD PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Patient Involvement (2645)
Event Date 08/25/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Customer had indicated that the product was being returned to zimmer biomet for investigation, but it has not yet been received. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported the tasp was found broken during clean up after an initial procedure.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE CD
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 Key10501629
MDR Text Key206090067
Report Number0001822565-2020-03172
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK172524
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/29/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/08/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42517000303
Device LOT Number63808393
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/16/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/29/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/27/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberN/A

-
-