MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE D; PROSTHESIS, KNEE

Model Number N/A

Device Problem Migration (4003)

Patient Problem Fall (1848)

Event Date 06/16/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10-medical product: femur trabecular metal (cr) standard porous, item# 42502805801, lot# 63773065.Articular surface (mc) left 12 mm height, item# 42512100312, lot# 64286787.Articular surface (mc) left 16 mm height, item# 42512100316, lot# 64517748.G2- australia.H3- 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.

Event Description

It was reported that a patient was revised approximately three years and four months post implantation due to tibia subsidence caused by repeated falls.Attempts to obtain additional information have been made; however, no more information is available.

Event Description

No additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were corrected: d10: remove articular surface (mc) left 12 mm height, item# 42512100312, lot# 64286787, as this device was not involved or associated in this event.The reported event was unable to be confirmed.Visual examination of the provided pictures identified explanted tibia, femur, and bearing.Radiographs were provided and reviewed by a healthcare professional, which identified possible early loosening of the tibial component and punctate metallic foreign body in the medial compartment.No operative records were received.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot 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.

• Brand Name: TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE D
• 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: 17277188
• MDR Text Key: 318555962
• Report Number: 0001822565-2023-01825
• Device Sequence Number: 1
• Product Code: MBH
• 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,Followup
• Report Date: 10/18/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42530006701
• Device Lot Number: 62939681
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/16/2023
• Initial Date FDA Received: 07/07/2023
• Supplement Dates Manufacturer Received: 10/16/2023
• Supplement Dates FDA Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2018
• 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 Sex: Female
• Patient Weight: 86 KG