MAUDE Adverse Event Report: ZIMMER BIOMET, INC. KNE-PERSONA-FEMORALS-UNK; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060)

Event Date 09/08/2020

Event Type  Injury  

Event Description

It was reported initial right tka was performed on unknown date.Subsequently experienced pain, limited rom, instability, stiffness and underwent a mua on an unknown date with no resolution of symptoms.A right tka revision was performed about 2 years post implantation.During the revision scar tissue was excised.Tibia, femur and articulating surface were revised/exchanged 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: kne-persona-bearings-unk, mdr: 0001822565-2022-03467; kne-persona-tibial trays-unk, mdr: 0001822565-2022-03469.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.  h6-component code- suggested code: mechanical (g04) - femur.No product was returned or pictures provided were insufficient to perform visual or dimensional evaluations.Part and lot identification are necessary for review of device history records, neither were provided.Insufficient information provided 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 operation notes identified the following: pain, instability, stiffness, and mua since initial surgery, rom: 10-105, x-ray: anterior slope, of tibia component, spinal, ebl 50 ml, no infection, scar tissue removed; flexion increased to 120, patella well fixed and remained intact, no loose component, no complications.The complaint was confirmed.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.

• Brand Name: KNE-PERSONA-FEMORALS-UNK
• 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: 15995001
• MDR Text Key: 305590316
• Report Number: 0001822565-2022-03468
• Device Sequence Number: 1
• Product Code: JWH
• 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: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• 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: 02/22/2023
• 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): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Race: White