MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TIBIA FIXED CEMENTED RIGHT SIZE E; PROSTHESIS, KNEE

Catalog Number 42542007102

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 03/29/2024

Event Type  Injury  

Event Description

It was reported that a patient underwent an initial right total knee arthroplasty on an unknown date.Subsequently, on an unknown timeframe post-implantation, the patient underwent revision surgery of the tibial component for an unknown reason.Due diligence is in progress for this event; to date no further information has been reported.

Manufacturer Narrative

(b)(4).D10: medical product: unknown tibial stem extension: catalog#: ni, lot#: ni; unknown articular surface: catalog#: ni, lot#: ni; unknown femoral component: catalog#: ni, lot#: ni.Diligence is in process to determine whether the product is available for evaluation.The investigation is in progress.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.

• Brand Name: PERSONA TIBIA FIXED CEMENTED RIGHT SIZE E
• 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: 19168785
• MDR Text Key: 340897467
• Report Number: 0001822565-2024-01384
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024562882
• UDI-Public: (01)00889024562882(17)310420(10)65000268
• 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: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2024

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 Catalogue Number: 42542007102
• Device Lot Number: 65000268
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/31/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/28/2021
• 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
• Treatment: SEE H11 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male