MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISTAL FEMORAL XT COMPONENT SIZE B LEFT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Fall (1848); Failure of Implant (1924); Pain (1994); Cancer (3262); Swelling/ Edema (4577)

Event Date 07/22/2022

Event Type  Injury  

Event Description

It was reported that a patient was revised approximately one year and seven months post implantation due to pain, swelling, and instability.Noted during the revision implant fracture, metal debris, and inflammatory tissue.The femur, hinge mechanism and stem exchanged with unknown products without complications.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2022-02234, 0001822565-2023-00097.Medical product: femoral hinge service kit xt size b item# 00585007112 lot# unknown.Articular surface with segmental hinge post size b 12 mm height item# 00585002012 lot# unknown.Report source- united kingdom.Customer has indicated that 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.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.Visual examination of the provided pictures identified explanted femur, hinge, and articular surface.The hinge was broken in the picture.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: hinge post was fractured, exchanged femur, hinge mechanism and poly, there was a tumor with posterior bulge towards the vessels, knee reconstruction was complete, stable rom, with good tracking, lots of inflammatory tissue excised.Two drains were placed as well as wound vac for five to six days, patient claims instability occurred prior to falls.Hinge mechanism snapped and poly shield broken down due to metal debris.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.A definitive root cause cannot be determined.If any further information is which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.H6: component code: proposed component (annex g) code is: mechanical (g04) - femur.

Event Description

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

Event Description

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

Manufacturer Narrative

This follow-up is being submitted to relay additional information.Visual examination of the returned product found it to exhibit signs of being implanted nicked /gouged / scratched.Medical records were sent and previously reviewed.This review remains unchanged.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.A definitive root cause cannot be determined.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.

• Brand Name: DISTAL FEMORAL XT COMPONENT SIZE B LEFT
• 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: 16130606
• MDR Text Key: 306996198
• Report Number: 0001822565-2023-00096
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 00889024195929
• UDI-Public: (01)00889024195929(17)301025(10)64892037
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K150028
• 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: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• 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: 00585004201
• Device Lot Number: 64892037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2020
• 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