MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA REVISION OFFSET SPLINED UNCEMENTED STEM EXTENSION 3MM X 17MM X +135MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Joint Contracture (4528)

Event Type  Injury  

Event Description

It was reported that the patient was prescribed dicoflenac to treat limited range of motion, flexion contracture, pain and stiffness approximately three (3) years following the patient's last left knee arthroplasty.Initial operative notes noted no intraoperative complications upon implantation of devices.

Manufacturer Narrative

(b)(4).D10 - concomitant devices - persona revision cemented femoral component plus left size 9+ catalog #: 42504606611 lot #: 64825710, persona revision central femoral cone size small catalog #: 42545001011 lot #: 64751267, persona revision femoral posterior augment cemented 9, 9+ 10mm catalog #: 42556806610 lot #: 64739717, persona revision femoral distal augment cemented size 9, 9+ 5mm catalog #: 42556606605 lot #: 64707485, persona revision femoral distal augment cemented size 9, 9+ 5mm catalog #: 42556606605 lot #: 64769986, persona revision femoral distal augment cemented size 9, 9+ 5mm catalog #: 42556606605 lot #: 64707485, persona revision constrained condylar knee articular surface left 12mm catalog #: 42512800712 lot #: 64615631.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.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001822565-2024-00664, 0001822565-2024-00665, 0001822565-2024-00666, 0001822565-2024-00667, 0001822565-2024-00668, 0001822565-2024-00669, 0001822565-2024-00670, 0001822565-2024-00671.H3 other text : investigation incomplete.

• Brand Name: PERSONA REVISION OFFSET SPLINED UNCEMENTED STEM EXTENSION 3MM X 17MM X +135MM
• 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: 18784209
• MDR Text Key: 336263870
• Report Number: 0001822565-2024-00665
• 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
• Report Date: 02/26/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42560313517
• Device Lot Number: 64769719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/09/2024
• Initial Date FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2020
• 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): Required Intervention
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White