MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN FEMORAL; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unstable (1667)

Patient Problem Insufficient Information (4580)

Event Date 11/27/2023

Event Type  Injury  

Manufacturer Narrative

(b)(6).Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2023-00348 and 0001822565-2023-03728.D10 medical devices: articular surface medial congruent (mc) left 10 mm height catalog#: 42512100810 lot#: 65034680 unknown tibial tray catalog#: ni lot#: ni g2 foreign source: australia customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient was revised approximately two years post-implantation due to instability.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6: suggested component code: mechanical (g04) - femur.The reported event was unable to be confirmed due to lack of proficient information; no product, images, or medical records provided.Review of the device history records was not performed for this device as lot number was not provided.The root cause of this event is unrelated to this device, as there were no allegations against it and is believed to have not contributed to the reported event.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 additional information to report.

• Brand Name: UNKNOWN FEMORAL
• 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: 18378900
• MDR Text Key: 331175799
• Report Number: 0001822565-2023-03728
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Sex: Male