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

Model Number N/A

Device Problems Loss of or Failure to Bond (1068); Unstable (1667); Insufficient Information (3190); Migration (4003)

Patient Problems Arthritis (1723); No Information (3190)

Event Date 10/15/2015

Event Type  malfunction  

Manufacturer Narrative

The part numbers and lot numbers are unknown; therefore, the device history records could not be reviewed and a product history search for related complaints could not be conducted.No devices were received; therefore, the condition of the components is unknown.This device is used for treatment.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.

Event Description

It is reported that an unknown number of patients were implanted with persona tm tibial components and are experiencing unknown symptoms.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is now reported that the patient was revised due to tibial loosening and subsidence.

Manufacturer Narrative

No devices were received; therefore the condition of the components is unknown and an evaluation is not possible.Review of the device history records for the tibial component identified no deviations or anomalies.The knee component compatibility was reviewed and identified no issues with any of the components.A product history search identified no other complaints for the part and lot combination of the tibial component.Primary operative notes state the patient underwent right total knee arthroplasty (tka) due to degenerative arthritis of the knee.Good stability and excellent kinematics through a full range of motion were noted during trialing.X-ray findings included in the primary operative report states that the prosthesis was in the proper position and in anatomic alignment without any evidence of rotation, loosening, or stress shielding.Operative notes from the revision surgery state that the tibial component was loose and had subsided.The femoral and patellar components were not revised.A field action was conducted on february 19, 2015 in which zimmer voluntarily removed the persona trabecular metal (tm) tibial implant from the field due to a higher than anticipated complaint rate for radiolucent lines and loosening.The device in question was implanted prior to this field action.Fda recall contains the related tibial lot number.The corrective actions investigation determined that the likely root causes for the higher than anticipated complaint rate are that the persona tm tibia allows the potential for the tibial implant to sit proud on the resected tibial surface and the persona tm tibia has less initial stability than predicate devices.

Manufacturer Narrative

Examination of the returned device confirms foreign debris in the tm pad and around the pegs.Nicks and gouges were noted on the finished surface.Review of the device history records for the tibial component identified no deviations or anomalies.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.

• Brand Name: PERSONA TWO PEG POROUS TIBIAL COMPONENT
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582-0708 ; 5745273773
• MDR Report Key: 5641623
• MDR Text Key: 44758259
• Report Number: 0001822565-2016-01507
• Device Sequence Number: 1
• Product Code: MBH
• 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: company representative,consum
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/24/2018

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 Model Number: N/A
• Device Catalogue Number: 42530007902
• Device Lot Number: 62490352
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2016
• Initial Date FDA Received: 05/09/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 08/01/2018
• Supplement Dates FDA Received: 06/16/2016; 10/14/2016; 08/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2013
• 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: 63 YR