MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA FEMUR TRABECULAR METAL (CR) STANDARD POROUS; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Adhesion(s) (1695); Scar Tissue (2060); Fibrosis (3167)

Event Date 04/03/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 medical devices: persona art.Surf.Fixed bearing (uc) left 10 mm height catalog#: 42512200510 lot#: 64463484 tibia cemented 5 degree stemmed left size e catalog#: 42532007101 lot#: 65425089 palacos r + g (1x40) catalog#: 66022663 lot#: 63661148 g2 foreign source: australia customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent a left knee arthroplasty.Subsequently, patient underwent a poly swap due to arthrofibrosis.Patient had better range of motion for a time but then it decreased due to fibrous tissue buildup.A further revision was performed to remove the entire knee and replace with a revision system.No further patient consequences have been reported.

• Brand Name: PERSONA FEMUR TRABECULAR METAL (CR) STANDARD POROUS
• 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: 19214908
• MDR Text Key: 341411031
• Report Number: 0001822565-2024-01438
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024230774
• UDI-Public: (01)00889024230774(17)321103(10)65658867
• 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
• Report Date: 04/30/2024

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: 42502806401
• Device Lot Number: 65658867
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H11
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male