MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TMT FEMORAL DIAPHYSEAL CONE, 30MM, MEDIUM, RIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Migration (4003)

Patient Problems Pain (1994); Metal Related Pathology (4530)

Event Date 03/02/2024

Event Type  Injury  

Event Description

It was reported that a patient underwent a right knee revision approximately eleven years post-implantation due to pain, metallosis, and disassociation of the femoral stem from the distal femoral implant.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-01000, 0001822565-2024-01001, and 0002648920-2024-00083.D10 medical devices: rotating hinge knee right size e cemented option femoral component catalog#: 00588001502 lot#: 62080614.Nexgen 14mm diameter 100mm length straight stem extension catalog#: 00598801014 lot#: 61748147.14mm height size e articular surface with hinge post extension catalog#: 00588005014 lot#: 62366280.Unknown rhk tibial tray catalog#: ni lot#: ni.Prc agmt block post sz e 10mm catalog#: 00599003502 lot#: 61405568.Prc agmt block post sz e 10mm catalog#: 00599003502 lot#: 62417507.Prc agmt block dist sz e 10mm catalog#: 00599003520 lot#: 61529985.Prc agmt block dist sz e 10mm catalog#: 00599003520 lot#: 61601937.G2 foreign source: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: TMT FEMORAL DIAPHYSEAL CONE, 30MM, MEDIUM, RIGHT
• 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: 18958792
• MDR Text Key: 338351396
• Report Number: 0001822565-2024-01001
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K103517
• 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: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: N/A
• Device Catalogue Number: 00545001831
• Device Lot Number: 61972314
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/29/2012
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 80 KG