MAUDE Adverse Event Report: ZIMMER, INC. PERSONA TRABECULAR METAL TWO-PEG POROUS TIBIAL COMPONENT RIGHT SIZE E; PROSTHESIS, KNEE

Catalog Number 42530007102

Device Problems Insufficient Information (3190); Migration (4003)

Patient Problems Pain (1994); Skin Discoloration (2074); Joint Swelling (2356); No Information (3190)

Event Date 06/15/2015

Event Type  Injury  

Event Description

It is reported that the pt is experiencing pain, swelling, discoloration, and a hot to the touch feeling of the knee.

Manufacturer Narrative

This report will be amended when out investigation is complete.

Manufacturer Narrative

The part and lot numbers are unknown; therefore the device history records could not be reviewed.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant devices - persona trabecular metal cruciate retaining narrow porous femoral component catalog #: 42502206602 lot #: 62696218, persona cruciate retaining articular surface right 11mm catalog #: 42521000511 lot #: 62304404, nexgen trabecular metal standard primary patella catalog #: 00587806535 lot #: 62647337.

Event Description

It is reported that the patient underwent a right knee arthroplasty revision to address pain, swelling and tibial component loosening approximately nine (9) months post-operatively.The patient's revision operative notes relayed that the tibial component was loose and was removed very easily.The component could be lifted without significant soft tissue or bony disruption and toggled with manipulation.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The product was evaluated through manufacturing review and the reported event was confirmed through review of medical records.The device history records were reviewed and no discrepancies were identified.As this device was recalled and implanted prior to the recall, the root cause is attributed to 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.

Event Description

No further event information available at the time of this report.

• Brand Name: PERSONA TRABECULAR METAL TWO-PEG POROUS TIBIAL COMPONENT RIGHT SIZE E
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER, INC.; po box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; po box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4826437
• MDR Text Key: 5841232
• Report Number: 1822565-2015-00855
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative,company representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/20/2019

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: 05/31/2024
• Device Catalogue Number: 42530007102
• Device Lot Number: 62584831
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/06/2015
• Initial Date FDA Received: 06/08/2015
• Supplement Dates Manufacturer Received: Not provided; 11/21/2018; 08/15/2019
• Supplement Dates FDA Received: 07/16/2015; 12/12/2018; 08/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2014
• 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): Other