MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TIBIA TRABECULAR METAL TWO-PEG POROUS FXD BRG RT SIZE G; PROSTHESIS, KNEE

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Pain (1994); Osteopenia/ Osteoporosis (2651)

Event Date 12/21/2023

Event Type  Injury  

Event Description

It was reported the patient presented with persistent pain, six months post implantation.Patient is scheduled to be revised on a future date for tibial loosening.No additional information at this time.

Manufacturer Narrative

(b)(4).G2: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products -------------------------------------------- 42522100910 articular surface medial congruent (mc) right 10mm lot# 65897411.42502806802 femur trabecular metal cruciate retaining standard porous lot# 6578197.

Event Description

It was reported the patient presented with persistent pain radiaiting from distal lower leg, six months post implantation.Xrays indicate possible lysis margin around the tibial peg.Patient was revised approximately two weeks after presenting with symptoms and the tibial implant exchanged.Articular surface also exchanged as a best practice.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.  visual examination of the returned product identified signs of being implanted (discoloration/scratched) and foreign material was found attached to the implant.Review of the device history records identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: office visit: persistent pain under load, sometime radiating to distal lower leg on the medical side.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: overall fit and alignment of the implants is appropriate.Mild osteopenia.No definite signs of loosening of the tibial or femoral components.Complaint is confirmed for pain from the provided medical records.The complaint could not be confirmed for loosening.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: PERSONA TIBIA TRABECULAR METAL TWO-PEG POROUS FXD BRG RT SIZE G
• 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: 18425907
• MDR Text Key: 331783761
• Report Number: 0001822565-2024-00011
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024510609
• UDI-Public: (01)00889024510609(17)320805(10)65542900
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K173417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 42530007902
• Device Lot Number: 65542900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 01/09/2024; 03/14/2024
• Supplement Dates FDA Received: 02/02/2024; 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2022
• 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: Male