MAUDE Adverse Event Report: ZIMMER, INC. PERSONA TM TWO-PEG NATURAL POROUS TIBIA; KNEE PROSTHESIS

Catalog Number 42530007902

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Code Available (3191)

Event Date 04/15/2015

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that a patient underwent revision of a total knee arthroplasty due to aseptic loosening of the right tibial tray with collapse.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical product-femur cemented posterior stabilized (ps) standard right size 11 catalog# 42500607002 lot# 62767613, articular surface fixed bearing posterior stabilized (ps) right 10 mm height catalog# 42522401010 lot# 62720734, palacos rg 1x40 single catalog# 00111314001 lot# 78714386 qty 2.No product was returned; visual and dimensional evaluations could not be performed.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required.Per the packaging insert associated with the device loosening and malalignment of the device are known inherent risks of the procedure.However, a definitive root cause cannot be determined 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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2016-03931, 0001822565-2017-05610, 0001822565-2017-05611.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Item returned and evaluation shows tibia has nicks and gouges.Foreign material was noted on most of the tm surface and bone cement was noted around the tm pegs.A prior field action was conducted in which zimmer voluntarily removed the persona trabecular metal 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.The root cause was determined to be due to a previously addressed design issue.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 TM TWO-PEG NATURAL POROUS TIBIA
• 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 ; 5745273773
• MDR Report Key: 6063112
• MDR Text Key: 58613025
• Report Number: 0001822565-2016-03931
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 42530007902
• Device Lot Number: 62620499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2014
• 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; Required Intervention
• Patient Age: 61 YR