MAUDE Adverse Event Report: ZIMMER, INC. PERSONA TWO PEG POROUS TIBIAL COMPONENT; PROSTHESIS, KNEE

Model Number N/A

Device Problems Failure To Adhere Or Bond (1031); Insufficient Information (3190)

Patient Problems Inadequate Osseointegration (2646); No Information (3190)

Event Date 02/23/2016

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that the patient is experiencing unknown injury due to the implant.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial report.Concomitant products: item # 42500807001, persona tm standard femoral, lot # 62688449; item # 42512401010, persona ps ve articular surface, lot # 62706147; item # 42540200035, persona ve all poly patella, lot # 62826593.

Event Description

It has now been reported that the patient was revised due to tibial loosening.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Corrected: common device name and product code.Reported event was confirmed through review of medical records.Review of device history record found no discrepancies relevant to the reported event.Root cause of the event is attributed to the design of the device, which has been the subject of a previous corrective action.It was determined that this device was manufactured prior to the corrective action.No further action is required at this time.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

Additional information received in revision operative report indicates failed right uncemented total knee arthroplasty secondary to failed bony ingrowth of the tibial component.

• Brand Name: PERSONA TWO PEG POROUS TIBIAL COMPONENT
• Type of Device: PROSTHESIS, 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: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5688405
• MDR Text Key: 46183957
• Report Number: 0001822565-2016-01818
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: PK121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 42530007901
• Device Lot Number: 62600891
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1266-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 64 YR