MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NATURAL TIBIA TM TWO-PEG POROUS FIXED BEARING RIGHT SIZE G; PROSTHESIS, KNEE

Model Number N/A

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 01/24/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: articular surface medial congruent (mc) right 10 mm height catalog#: 42522100910 lot#: 64758250.Femur trabecular metal cruciate retaining (cr) standard porous catalog#: 42502807002 lot#: 64640897, foreign source: (b)(6).Reported event was unable to be confirmed due to limited information received from the customer.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: there is a periprosthetic lucency surrounding the medial peg of the tibial component which is likely related to loosening and could contribute to subsidence.There appears to be slight inferior depression of the medial component of the hardware which can be related to subsidence, although subsidence requires 2 time points to confirm with progression from one time point to the next.Bone quality appears normal.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that patient underwent a right knee revision approximately a year post-implantation due to tibial subsidence.Attempts to obtain additional information have been made; however, no more is available.

• Brand Name: NATURAL TIBIA TM TWO-PEG POROUS FIXED BEARING RIGHT SIZE G
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13966312
• MDR Text Key: 288297201
• Report Number: 0001822565-2022-00858
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 0088904510609
• UDI-Public: (01)0088904510609(17)290831(10)64405957
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K173417
• 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: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42530007902
• Device Lot Number: 64405957
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2019
• 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): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 119 KG