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

MAUDE Adverse Event Report: ZIMMER, INC. PERSONA TM TWO-PEG POROUS FIXED BEARING TIBIA 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, INC. PERSONA TM TWO-PEG POROUS FIXED BEARING TIBIA LEFT SIZE E PROSTHESIS, KNEE Back to Search Results
Catalog Number 42530007101
Device Problems Failure To Adhere Or Bond (1031); Migration or Expulsion of Device (1395)
Patient Problem No Information (3190)
Event Date 02/16/2016
Event Type  Injury  
Event Description

It is reported that the patient is experiencing loosening.

 
Manufacturer Narrative

(b)(4). The part and lot numbers are unknown; therefore the device history records could not be reviewed. No devices or photos were received; therefore the condition of the components is unknown. Surgical notes were not provided. It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique. A definitive root cause cannot be determined with the information provided.

 
Manufacturer Narrative

This follow-up report is being submitted to relay additional information. Concomitant medical product: - persona tm narrow porous femoral, catalog #: 42502206001, lot #: 62737836. Nexgen tm standard primary patella, catalog #: 00587806535, lot #: 62640404. Persona articular surface fixed bearing, catalog #: 42512000510, lot #: 62720692. 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 has now been reported that following a total knee arthroplasty, the patient underwent a tibial revision due to loosening.

 
Manufacturer Narrative

This follow-up report is being submitted to relay additional information. Reported event was confirmed by review of op notes. The revision operative notes were provided as well. The revision procedure was indicated for mechanical loosening of the tibial component. It was noted that the femoral and patellar components were well-fixed and were not removed. The tibial component was removed and it was noted that 50% of the tibial plate had ingrowth while the other half did not. Device history record was reviewed and no discrepancies relevant to the reported event were found. The design of the device is the root cause of the event. 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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePERSONA TM TWO-PEG POROUS FIXED BEARING TIBIA LEFT SIZE E
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER, INC.
p.o. box 708
warsaw IN 46581 0708
Manufacturer (Section G)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer Contact
christina arnt
56 e. bell dr.
p.o. box 708
warsaw, IN 46582-0708
5745273773
MDR Report Key4801137
MDR Text Key5835985
Report Number1822565-2015-00767
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK121771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/04/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/26/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number42530007101
Device LOT Number62495347
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/02/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/14/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/26/2015 Patient Sequence Number: 1
-
-