MAUDE Adverse Event Report: ZIMMER, INC. PERSONA TRABECULAR METAL POROUS 2 PEGGED TIBIAL COMPONENT; KNEE PROSTHESIS

Catalog Number 42530008302

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 11/01/2016

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that the patient is scheduled to undergo knee arthroplasty revision due to tibial loosening.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Concomitant medical product - persona vivacit-e highly crosslinked polyethylene articular surface fixed bearing cruciate retaining (cr) catalog# 42522000610 lot# 62351242, nexgen trabecular metal standard primary patella catalog#00587806541 lot# 61668516, persona femur trabecular metal cruciate retaining (cr) catalog# 42502806802 lot# 62447377.

Event Description

It was reported patient underwent a revision procedure due to tibial loosening and pain approximately 3 years post implantation.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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 TRABECULAR METAL POROUS 2 PEGGED TIBIAL COMPONENT
• Type of Device: KNEE PROSTHESIS
• 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: christina arnt ; p.o. box 708; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6076016
• MDR Text Key: 59057650
• Report Number: 0001822565-2016-03973
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 42530008302
• Device Lot Number: 62413416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 54 YR