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

Catalog Number 42530006701

Device Problems Failure To Adhere Or Bond (1031); Unstable (1667)

Patient Problem No Information (3190)

Event Date 02/09/2016

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that the after a knee arthroplasty, the patient was revised due to instability and tibial component subsidence.

Manufacturer Narrative

Concomitant medical products: item name: persona femal trabecular metal cr narrow, item number: 42502206601, lot number: 62718155.Item name: persona articular surface cr, item number: 42512000410, lot number: 62559445.Item name: nexgen tm patella, item number:.00587806532 , lot number: 62708947.Reported event was unable to be confirmed due to limited information received from the customer.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 as no were trends identified.The devices were evaluated for compatibility with no issues found.Per the packaging insert associated with the device malignment and instability of the knee components are a known inherent risk of the procedure.However, a 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.

• Brand Name: PERSONA POROUS TWO PEG 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 ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6033305
• MDR Text Key: 57618383
• Report Number: 0001822565-2016-03698
• 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
• Report Date: 07/29/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 42530006701
• Device Lot Number: 62534804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2016
• Initial Date FDA Received: 10/17/2016
• Supplement Dates Manufacturer Received: 07/27/2017
• Supplement Dates FDA Received: 07/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR