MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PARTIAL ARTICULAR SURFACE RIGHT MEDIAL SIZE C 8 MM THICKNESS; PROSTHESIS, KNEE

Model Number 42-5282-003-08

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

Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/24/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product: unknown cement: catalog#ni, lot#ni.Report source: foreign: (b)(6).Customer has indicated that product will not be returned to zimmer biomet for investigation, as the product has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent an initial partial right knee arthroplasty.Six months post implantation, the patient returned reporting pain.Images showed evidence of cement that had broken apart behind the tibial tray.During the surgery, it appeared that the patient had some further degeneration in the knee and cement was seen in the joint.During the revision, the surgeon removed the articular surface, cleaned out the knee of cement debris, and implanted a new articular surface.The surgeon reported the reason for revision as pain, chondral degeneration and cementophite.The cement used was not zimmer biomet cement.

Event Description

No further event information at time of this report.

Manufacturer Narrative

Visual examination of the provided picture identified an articular surface with foreign material on it and three unknown foreign bodies.The rim of the articular surface appears to be damaged (gouged), no other definitive statements can be made.Device history record was reviewed and no discrepancies related to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: implants are anatomically aligned, no fracture is present, bone quality is osteopenic, multiple cement fragments are seen, no evidence of loosening, chondral degeneration cannot be confirmed root cause was unable to be determined.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10: associated medical products: partial tibial cemented size c right medial: catalog#42538000302, lot#64427216; partial femur cemented size 3 right medial: catalog#42558000302, lot#64767076; copal g + c bone cement: catalog#66041214, lot#95374959.Additional information provided does not alter previously reported investigation results.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.

Event Description

No further event information at time of this report.

• Brand Name: PARTIAL ARTICULAR SURFACE RIGHT MEDIAL SIZE C 8 MM THICKNESS
• 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: 12633049
• MDR Text Key: 276418493
• Report Number: 0001825034-2021-02869
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00880304817999
• UDI-Public: (01)00880304817999(10)250521(17)64660713
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K161592
• 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: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 42-5282-003-08
• Device Catalogue Number: 42528200308
• Device Lot Number: 64660713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2020
• 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: Female