MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRABECULAR METAL CONE FULL; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problem Pain (1994)

Event Date 03/27/2024

Event Type  Injury  

Event Description

It was reported that patient underwent a left knee revision approximately six years post-implantation due to femoral pain.No additional patient consequences were reported.

Manufacturer Narrative

(b)(4).D10 medical devices: nexgen 14mm height size c,d with locking screw yellow articular surface catalog#: 00599403014, lot#: 62938369.Nexgen left size d cemented option femoral component catalog#: 00599401491, lot#: 63746608.Nexgen 18mm diameter 100mm length straight stem extension catalog#: 00598801018, lot#: 63282086.Nexgen stemmed tibial component precoat size 3 catalog#: 00598003701, lot#: 63544274.Nexgen 14mm diameter 100mm length offset stem extension catalog#: 00598802014, lot#: 63632065.Prc agmt block dist sz d 5mm catalog#: 00599003410, lot#: 62963054.Prc agmt block dist sz d 5mm catalog#: 00599003410, lot#: 62999435.Competitor bone cement catalog#: unk, lot#: unk.G2 foreign source: new zealand.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: TRABECULAR METAL CONE FULL
• 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: 19159850
• MDR Text Key: 340791069
• Report Number: 0001822565-2024-01362
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K053340
• 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: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 00545004801
• Device Lot Number: 63525256
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/18/2016
• 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 H10.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female