MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA REVISION VIVACIT-E CCK ARTICULAR SURFACE LEFT 14MM WITH LOCKING SCREW; PROSTHESIS, KNEE

Model Number N/A

Device Problems Unstable (1667); Noise, Audible (3273); Migration (4003)

Patient Problem Pain (1994)

Event Date 04/27/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - concomitant devices - persona revision cemented femoral component plus size 9+ left catalog #: 42504606611 lot #: 64463034, persona offset splined uncemented stem extension 3mm x 16mm catalog #: 42560313516 lot #: 64523184, persona revision femoral cemented distal augment size 9, 9+ 5mm catalog #: 42556606605 lot #: 64416178, persona revision femoral cemented distal augment size 9, 9+ 5mm catalog #: 42556606605 lot #: 64362194, persona revision cemented tibial tray left size d catalog #: 42542006701 lot #: 64334561, persona offset splined uncemented stem extension 3mm x 14mm catalog #: 42560313514 lot #: 64573160, persona tibial cone catalog #: 42545000508 lot #: 64154173, refobacin bone cement r 1x40 us catalog #: 110034355 lot #: 848aad1612, persona tibial cone catalog #: 42545000508 lot #: 64154173, refobacin bone cement r 1x40 us catalog #: 110034355 lot #: 838baf1806, refobacin bone cement r 1x40 us catalog #: 110034355 lot #: 838baf1806 the complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.H3 other text : investigation incomplete.

Event Description

It was reported that the patient is being considered for a left knee arthroplasty revision to address pain, stiffness and instability as a result of the articular surface locking screw backing out approximately three (3) years post-operatively.The revision is unable to be performed at this time due to the patient's availability, however, the revision will be planned once the patient is able to do so.Initial operative notes noted no intraoperative complications.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, b6, g3, g6, h2, h6, h10.

Event Description

It was reported that the patient is being considered for a left knee arthroplasty revision to address pain, stiffness, instability and implant noise as a result of the articular surface locking screw backing out approximately three (3) years post-operatively.The patient is being scheduled for a revision when available.Initial operative notes noted no intraoperative complications.

• Brand Name: PERSONA REVISION VIVACIT-E CCK ARTICULAR SURFACE LEFT 14MM WITH LOCKING SCREW
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18685829
• MDR Text Key: 335132261
• Report Number: 0001822565-2024-00474
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 42512800514
• Device Lot Number: 64195975
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2018
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 110 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White