MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA REVISION CENTRAL FEMORAL CONE SIZE SMALL; 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 offset splined uncemented stem extension 3mm x 17mm x +135mm catalog #: 42560313517 lot #: 64769719, 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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 REVISION CENTRAL FEMORAL CONE SIZE SMALL
• 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: 18784230
• MDR Text Key: 336263972
• Report Number: 0001822565-2024-00666
• 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: 08/02/2024

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: 42545001011
• Device Lot Number: 64751267
• 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
• Supplement Dates Manufacturer Received: 07/29/2024
• Supplement Dates FDA Received: 08/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2020
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White