MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 10 MM HEIGHT; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problem Pain (1994)

Event Date 03/26/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 medical devices: persona tibia tm two-peg porous fixed bearing left size e catalog#: 42530007101 lot#: 65261953.Femur trabecular metal cruciate retaining (cr) narrow porous catalog#: 42502206201 lot#: 65517127.Nexgen complete knee solution, trabecular metal standard primary patella catalog#: 00587806532 lot#: 65389351.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was requested but not returned by the hospital.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 revision approximately seventeen months post-implantation due to a painful tibia.The tibial tray and insert were removed and replaced.

• Brand Name: PERSONA ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 10 MM HEIGHT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19155495
• MDR Text Key: 340750587
• Report Number: 3007963827-2024-00132
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024469211
• UDI-Public: (01)00889024469211(17)260914(10)65141833
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• 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 Model Number: N/A
• Device Catalogue Number: 42512100710
• Device Lot Number: 65141833
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/06/2021
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 110 KG