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

Model Number 42-5300-064-02

Device Problems Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Osteopenia/ Osteoporosis (2651)

Event Date 04/26/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: medical product: femur trabecular metal cruciate retaining (cr) standard porous: catalog#42502805402, lot#64071425; articular surface fixed bearing cruciate retaining (cr) right 10 mm height: catalog#42522000410, lot#65897421.G2: foreign: japan.Customer has indicated that the product is in process of being returned to zimmer biomet for evaluation.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.H3 other text : see h10 narrative.

Event Description

It was reported that a patient underwent an initial right total knee arthroplasty.Subsequently, one week post-implantation, the patient presented at the clinic after feeling a pain.Diagnostics confirmed that the patient's proximal medial tibial bone was fractured with loosening and sinking of the tibial tray.The surgeon noted a valgus deformity and brittle bone of the patient's tibia.A revision surgery was performed to replace the tibial components without complication.It was reported that no further information is available.

Event Description

No further event information at time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified signs of being implanted (scratched/nicked) along with foreign material on the distal surface.Device history record was reviewed and no discrepancies related to the reported event were found.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: periprosthetic fracture in the medial proximal tibia adjacent to the medial tibial plate with resultant varus alignment of the knee.No signs of loosening, wear, radiolucency.There is kinking/subsidence of the medial tibial plate related to periprosthetic fracture.No contributing factors identified.Root cause was unable to be determined.This complaint is confirmed with provided medical records.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: NATURAL TIBIA TM TWO-PEG POROUS FIXED BEARING RIGHT SIZE C
• 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: 16912250
• MDR Text Key: 315012580
• Report Number: 0001822565-2023-01292
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024510524
• UDI-Public: (01)00889024510524(17)320628(10)65509841
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 07/17/2023

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: 42-5300-064-02
• Device Catalogue Number: 42530006402
• Device Lot Number: 65509841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/26/2023
• Initial Date FDA Received: 05/11/2023
• Supplement Dates Manufacturer Received: 07/13/2023
• Supplement Dates FDA Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2022
• 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: Prefer Not To Disclose