MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK TIBIAL; PROSTHESIS, KNEE

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Ossification (1428); Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032)

Event Date 07/07/2020

Event Type  Injury  

Event Description

Initial left total knee arthroplasty performed on an unknown date with unknown implants.Subsequently, the patient was revised due to instability.Approximately one year and eight months post revision , the patient was revised again due to pain.During the revision the tibial baseplate was found to be grossly loose with the implant delaminated from the underlying cobalt cement as well as varus angulation of the tibia secondary to progressive remodeling of the proximal tibial.It was determined that the patient would need a complete revision.All components were explanted without complications.

Manufacturer Narrative

(b)(4).The product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products & mdrs 183424 vngd cr tib brg 14x63/67 lot# 175710; mdr: 0001825034-2023-02534.141205 biomet tibial locking bar lot# 515910; mdr: 0001825034-2023-02535.Additional associated products: unk bone cement.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.  no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Insufficient information provided.Unable to perform a compatibility check.Complaint history review cannot be performed without product identification.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: pain due to left tka; grossly loose tibial baseplate with the implant delaminated from the underlying cobalt cement; due to tibial baseplate being hung up on lateral femoral condyle and underlying instability, it was felt a full revision was necessary.Complaint is confirmed from provided medical records.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this 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 further event information available at the time of this report.

• Brand Name: UNK TIBIAL
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18021914
• MDR Text Key: 326793872
• Report Number: 0001825034-2023-02540
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 02/12/2024
• 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 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female