MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA - NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING RIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problems Unstable (1667); Migration (4003)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Discomfort (2330)

Event Date 08/24/2018

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint number - (b)(4).Concomitant medical products: articular surface fixed bearing cruciate retaining (cr) right, catalog #: 425220005111, lot #: 62513974; femur trabecular metal cruciate retaining (cr) standard porous, catalog #: 42502806602, lot #: 62573826; nexgenâ® complete knee solution, trabecular metal standard primary patella, catalog #: 00587806538, lot #: 62536481.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product is retained by the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient underwent a right initial knee arthroplasty.Subsequently, the patient underwent a revision procedure approximately four years post-implantation due to tibial subsidence of 5-6mm due to possible lack in anterior cortical rim coverage.It was further noted that the tibia was thought to be loose/unstable.Operative reports indicate that the patient has a history of effusion in the knee which is most likely due to rheumatoid arthritis.The patient was also noted to have pain, swelling and discomfort in the right knee and the patient is unable to walk long distances.

Manufacturer Narrative

This follow-up report is being filed to relay this report is a duplicate of 0001822565-2018-03842.

Event Description

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

• Brand Name: PERSONA - NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING RIGHT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• 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: 7915885
• MDR Text Key: 121943229
• Report Number: 0001822565-2018-05337
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 42530007502
• Device Lot Number: 62434349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2013
• 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; Required Intervention
• Patient Age: 69 YR