MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA FEMUR TRABECULAR METAL CRUCIATE RETAINING; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Fall (1848); Bone Fracture(s) (1870); Pain (1994)

Event Date 03/23/2024

Event Type  Injury  

Event Description

It was reported that the patient underwent a knee revision approximately 16 days post implantation due to a periprosthetic fracture after a fall.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).G2: foreign - australia.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.

Event Description

It was reported that the patient underwent a right knee revision approximately 15 days post implantation due to pain and periprosthetic fracture from falling while walking to bathroom using a four-wheel walker and nursing assistance.All components exchanged with nexgen rotating hinge components without complications.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.An investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.

• Brand Name: PERSONA FEMUR TRABECULAR METAL CRUCIATE RETAINING
• 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: 19111139
• MDR Text Key: 340226404
• Report Number: 0001822565-2024-01240
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024230767
• UDI-Public: (01)00889024230767(17)340202(10)66339306
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/03/2024

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: 42502806202
• Device Lot Number: 66339306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/24/2024
• Initial Date FDA Received: 04/15/2024
• Supplement Dates Manufacturer Received: 04/15/2024
• Supplement Dates FDA Received: 05/06/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/09/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose