• 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 ARTICULAR SURFACE FIXED BEARING 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 ARTICULAR SURFACE FIXED BEARING PROSTHESIS, KNEE Back to Search Results
Catalog Number 42512401010
Device Problems Failure To Adhere Or Bond (1031); Noise, Audible (3273)
Patient Problems Pain (1994); Swelling (2091)
Event Date 06/07/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4). Medical products: unknown persona femoral component, item # unknown, lot # unknown; unknown persona bearing, item # unknown, lot # unknown. Customer has indicated that the product will not be returned to zimmer biomet for investigation due to the device remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-04616 and 0001822565-2017-04618.

 
Event Description

It was reported following an initial knee arthroplasty, the patient is being considered for a revision due to unknown reasons. The patient is experiencing pain, swelling, loosening, and popping. The patient underwent two manipulations since the initial procedure. Attempts have been made and additional information on the reported event is unavailable. No additional patient consequences were reported.

 
Manufacturer Narrative

This follow-up report is being submitted to relay additional information. The following sections were updated: event date- (b)(6) 2017. It was reported following a left knee arthroplasty, the patient underwent a manipulation. The patient is experiencing loosening, swelling, popping and snapping. No additional patient consequences were reported. 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 following a left knee arthroplasty, the patient underwent a manipulation. The patient is experiencing loosening, swelling, popping and snapping. No additional patient consequences were reported.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePERSONA ARTICULAR SURFACE FIXED BEARING
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer (Section G)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6690208
MDR Text Key79177715
Report Number0001822565-2017-04619
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 COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/06/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/06/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2019
Device Catalogue Number42512401010
Device LOT Number62866060
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/06/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/15/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/06/2017 Patient Sequence Number: 1
-
-