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

Model Number N/A

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

Patient Problem Pain (1994)

Event Date 04/27/2016

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that the patient was revised due pain and possible loosening.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.This report is being amended to reflect changes.This report is 1 of 2 for this patient: 0001822565-2016-01726/0001822565-2016-01823.

Event Description

It is now known that the tibial component had subsided anteriorly.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical product: persona femur trabecular metal cr narrow left, catalog #42502206001 lot #62679524; persona articular surface fixed bearing cr left, catalog #42512000411 lot #62476426.Reported event was confirmed through review of operative notes provided.Left knee revision operative notes indicate painful left total knee replacement.During the revision, it was noted the implant did not show any gross, obvious loosening, but looked to have subsided anteriorly.Revision implants were noted as well-fitting with good stability with no interoperative complications noted.Device history records were reviewed and no discrepancies were found.As the patient was revised due to possible loosening of the tibial component, it is noted that a 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.Therefore, the root cause is tied with the design of the device.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: OIY
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): .; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582-0708 ; 5745273773
• MDR Report Key: 5678095
• MDR Text Key: 45858025
• Report Number: 0001822565-2016-01726
• 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: distributor,health profession
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 06/06/2017

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 42530006701
• Device Lot Number: 62490339
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2016
• Initial Date FDA Received: 05/25/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/28/2016; 06/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2013
• 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; Required Intervention
• Patient Age: 62 YR