MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN OSS EXPANDABLE FEMUR; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problem Impaired Healing (2378)

Event Date 09/16/2022

Event Type  Injury  

Event Description

A journal article was retrieved from journal of surgical oncology (2022) that reported a study from the west coast of the united states.The purpose of the retrospective cohort study was to report the outcome of pediatric patients with a primary bone sarcoma at the distal femur reconstructed with a compress/oss distal femur expandable endoprosthesis and to determine the survivorship of the cps spindle, modes of failure using the international society of limb salvage (isols) classification and the rate of and risks associated with prosthetic joint infections.The study reviewed 36 patients who underwent surgery between a 20-year timeframe at 5 study centers.All patients were treated for primary oncologic diagnoses of osteosarcoma (34) or ewing sarcoma (2).The study population had a mean age of 10.7 years at time of surgery and range of 5 to 15 years old; 24 males/12 females.Follow-up was conducted for a minimum of 2 years (range: 10-246 months).The study reported 9 patients underwent additional surgery due failure of soft tissue coverage type 1b (wound complications).Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).G2 - literature: tanaka ks, andaya vr, thorpe sw, et al.Survival and failure modes of the compress® spindle and expandable distal femur endoprosthesis among pediatric patients: a multi-institutional study. j surg oncol.2023;127(1):148-158.Doi:10.1002/jso.27094 the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.It is expected that a wound heals in stages and should be of normal appearance related to the timeframe since the incision was made.A surgical wound should be well approximated without redness, warmth, swelling and/or purulent drainage for the duration of its healing.The expression ¿wound concerns¿ or "non-healing wound¿ would imply that the appearance of the wound deviates from what a surgical wound should appear.It may be red, have drainage, additional pain, warmth and swelling as well as healing time may be delayed.This deviation signifies an alteration in the wound healing process which can be complicated by patient comorbidities such as diabetes, obesity, smoking, and other conditions that are known to slow a person¿s ability to heal.Wound complications can be treated conservatively or more invasively with an irrigation and debridement (i&d) which promotes healing at the site and prevents further complications.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.

Event Description

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

• Brand Name: UNKNOWN OSS EXPANDABLE FEMUR
• 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: 17313636
• MDR Text Key: 319024877
• Report Number: 0001825034-2023-01564
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 9
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/14/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/26/2023
• Initial Date FDA Received: 07/12/2023
• Supplement Dates Manufacturer Received: 09/14/2023
• Supplement Dates FDA Received: 09/15/2023
• 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
• Patient Outcome(s): Hospitalization; Required Intervention