MAUDE Adverse Event Report: ZIMMER, INC. PERSONA PEGGED POROUS TIBIAL COMPONENT

Catalog Number 42530006401

Device Problems Failure To Adhere Or Bond (1031); Migration or Expulsion of Device (1395)

Patient Problems Cyst(s) (1800); No Information (3190)

Event Date 09/02/2014

Event Type  Injury  

Event Description

It was reported that the patient was revised due to loosening.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

Evaluation summary: review of the returned radiographs does not indicate root cause.Radiolucency is noted distal to the lateral peg of the tibial component.The quality of the returned radiographs is poor.Review of the primary operative notes does not indicate root cause.Excellent range of motion and stability were noted during the trial reduction and with the final implants.Revision operative notes indicate the tibial component was found to be grossly loose.Cystic defects were noted underneath the tibial component.A field action was conducted on february 19, 2015 in which zimmer voluntarily removed the persona trabecular metal tibial implant from the field due to a higher than expected complaint rate for radiolucent lines and loosening.This field action has been reported to the fda under 1822565-02-10-2015-002-r.The device in question was implanted prior to this field action.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Medical product: persona femoral posterior stabilized, catalog#: 42500006001, lot#: 62435218.Persona female screw, catalog#: 42509902525, lot#: 62348084.Persona female screw, catalog#: 42509902548, lot#: 62417037.Persona articular surface, catalog#: 42512400510, lot#: 62377566.Reported event was confirmed by review of revision operative notes and x-rays.Investigation results concluded that the reported event was due to a design issue that allows the potential for the persona tm tibia implant to sit proud on the resected tibial surface and the persona tm tibia has less initial stability than predicate devices.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 is reported that the patient's left knee was revised due to loosening of the tibial component.Revision op notes mention cystic defects under the revised baseplate.Patient was revised to a zimmer cck knee.

• Brand Name: PERSONA PEGGED POROUS TIBIAL COMPONENT
• Manufacturer (Section D): ZIMMER, INC.; p.o. box 708; warsaw IN 46581 0708
• 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 Key: 4417942
• MDR Text Key: 5371062
• Report Number: 1822565-2015-00007
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor,distributor,health prof
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 42530006401
• Device Lot Number: 62471385
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/09/2014
• Initial Date FDA Received: 01/07/2015
• Supplement Dates Manufacturer Received: 01/08/2015; 03/22/2018; 03/22/2018
• Supplement Dates FDA Received: 02/04/2015; 03/31/2015; 03/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1822565-02-10-2015-002R
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention