MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE SIZE 4 8 MM HEIGHT; PROSTHESIS, KNEE

Model Number 5842-24-08

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

Patient Problems Pain (1994); Synovitis (2094); Swelling/ Edema (4577)

Event Date 10/16/2020

Event Type  Injury  

Event Description

It was reported that a patient underwent a left knee procedure.Subsequently, for two years post implantation, the patient has had persistent and ongoing pain, swelling, and difficulty with daily activities.The patient experiences a scraping sensation and sharp focal pain when the knee is bent past 90 degrees.At one year post implantation, two ultrasounds were completed which suggested synovitis and degenerative changes affecting the iliotibial band and the lateral collateral ligament.Medical evaluations and extensive rehabilitation have not improved symptoms and imaging studies reportedly show severe irritation to the lateral collateral ligament at the location of the implanted components.At this time, no further medical intervention has been reported and the products remain implanted.

Manufacturer Narrative

(b)(4).Concomitant medical products: tibial component precoat right medial/left lateral size 4, catalog#: 00584200402, lot#: 63838877.Femoral component high flex precoat for cemented use only right medial/left lateral, catalog#: 00584201502, lot#: 64654549.Palacos fast r+g 1x40, catalog#: 66056768, lot#: 95434925.Report source: foreign: australia.Multiple mdr reports have been filed for this event.Please see associated reports: 0001822565-2022-02494; 0001822565-2022-02496.Visual and dimensional evaluations could not be performed as no product was returned.Photograph provided shows that the left knee is swollen.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient xray and ultrasound show severe irritation to lcl, multiple orthopedic evaluations, patient is lean and fit at baseline.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ARTICULAR SURFACE SIZE 4 8 MM HEIGHT
• 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: 15327574
• MDR Text Key: 298982179
• Report Number: 0001822565-2022-02495
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00889024194021
• UDI-Public: (01)00889024194021(17)270831(10)64500538
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K033363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5842-24-08
• Device Catalogue Number: 00584202408
• Device Lot Number: 64500538
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 70 KG