• 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. TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE C 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. TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE C PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Migration (4003)
Patient Problems Pain (1994); No Information (3190)
Event Date 12/24/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Explant date: unknown day in (b)(6) 2019. Report source: (b)(6). Customer has not indicated whether or not the product will be returned to zimmer biomet for investigation. 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 due to subsidence. There is no additional information at this time.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE C
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 Key9591710
MDR Text Key175066918
Report Number0001822565-2020-00178
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK172524
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 04/01/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/15/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42532006401
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 Received03/30/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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 TREATMENT DATA
Date Received: 01/15/2020 Patient Sequence Number: 1
-
-