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

MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. NATURAL TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE E 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 ORTHOPAEDIC MFG. LTD. NATURAL TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE E PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Loss of or Failure to Bond (1068); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem No Code Available (3191)
Event Date 09/09/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). Multiple mdr reports were filed for this event, please see associated report: 3007963827-2020-00223. Medical product, femur cemented posterior stabilized (ps) standard left size 8. Item# 42500606401, lot# 62833482. Articular surface fixed bearing posterior stabilized (ps) left 16 mm height. Item# 42511400716, lot# 62969873. (b)(6). Customer has indicated that the product will not 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 approximately one year and nine months' post implantation due to aseptic loosening. There is no additional information at this time.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNATURAL TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE E
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER ORTHOPAEDIC MFG. LTD.
building no 2 east park
shannon industrial estate
shannon, county clare
EI
Manufacturer (Section G)
ZIMMER ORTHOPAEDIC MFG. LTD.
building no 2 east park
shannon industrial estate
shannon, county clare
EI
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key10542137
MDR Text Key207206726
Report Number3007963827-2020-00224
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK172524
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 09/16/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/16/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42532007101
Device LOT Number64082706
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 Received09/09/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured06/29/2018
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: 09/16/2020 Patient Sequence Number: 1
-
-