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

Model Number N/A

Device Problem Mechanical Problem (1384)

Patient Problem Failure of Implant (1924)

Event Date 09/16/2022

Event Type  Injury  

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.

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 that the expandable component failed in 8 patients; of which, 3 were due to failure resulting in loss of expansion.Attempts have been made and no further information has been provided.

Event Description

The study reported that the expandable component failed in 8 patients; of which, 3 were due to failure resulting in loss of expansion.It was further reported that the failures were the due to the expansions collapsing, which caused the telescoping portion to go completely flat.

Manufacturer Narrative

No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause cannot 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: 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: 17313623
• MDR Text Key: 319094368
• Report Number: 0001825034-2023-01559
• 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: 3
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• 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: 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
• Date Manufacturer Received: 07/26/2023
• 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): Required Intervention; Hospitalization