MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMUR TRABECULAR METAL (CR) STANDARD POROUS; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Fall (1848); Pain (1994); Swelling/ Edema (4577)

Event Date 05/25/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated report: 3007963827-2023-00201.D10- medical product articular surface (mc) left 12 mm height; item# 42512100312; lot# 64286787.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 one year three and a half months post implantation due to instability.The patient had both pain and swelling prior to the revision.The surgeon doesn't believe that the original components (or failure of) contributed to the fall(s) of the patient.Attempts to obtain additional information have been made; however, no more information is available.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.No devices or photos were received; therefore, the condition of the components is unknown.X-ray review by third party hcp states that punctate metallic foreign body medial compartment.Large ossific densities in the region of the suprapatellar bursa on the lateral film.Mildly hyperdense suprapatellar joint effusion is of uncertain clinical significance.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.Root cause cannot be determined.This complaint cannot be confirmed for pain and instability however swelling can be confirmed via x-rays provided.H6: component code: proposed component (annex g) code is: - mechanical (g04) - femur.If any further information is received 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 available at the time of this report.

• Brand Name: FEMUR TRABECULAR METAL (CR) STANDARD POROUS
• 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: 17490796
• MDR Text Key: 320733153
• Report Number: 0001822565-2023-02073
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024230712
• UDI-Public: (01)00889024230712(17)270930(10)63773065
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K122745
• 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: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• 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: 42502805801
• Device Lot Number: 63773065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2017
• 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: Female
• Patient Weight: 86 KG