MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL TRAY FIXED BEARING SIZE 4; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Pain (1994); Osteolysis (2377); Insufficient Information (4580)

Event Date 11/21/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2023-03567.0001822565-2023-03569.D10-medical product cruciate retaining cr-flex (gsf) femoral component porous item# 00575201502 lot# 61419506 unknown articular surface g2- australia h3- customer has not indicated whether the product will 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 due to unknown reasons.Attempts to obtain additional information have been made; however, no more information is available at this time.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.

Event Description

It was reported that a patient was revised approximately twelve years post implantation due to sudden onset pain.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h10.No product was returned; visual and dimensional evaluations could not be performed.Review of the provided photos identified poly wear consistent with use and bio debris on the femoral and tibia plate components.No furher evaluation could be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: extensive peri-implant osteolysis.A definitive root cause cannot be determined.This complaint cannot be confirmed for pain.Osteolysis was confirmed per x-rays.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

No further event information is available at the time of this report.

• Brand Name: TIBIAL TRAY FIXED BEARING SIZE 4
• 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: 18305609
• MDR Text Key: 330220101
• Report Number: 0001822565-2023-03568
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K072160
• 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,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00595403702
• Device Lot Number: 62253907
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2013
• 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
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female