MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah DISTAL FEM GROWING PROSTHESIS LEFT 150MM; Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer

Catalog Number	6497-1-150
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A pediatric growing prosthesis collapsed and had to be exchanged for a gmrs distal femur.

• Brand Name: DISTAL FEM GROWING PROSTHESIS LEFT 150MM
• Common Device Name: Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer
• Manufacturer (Section D): Stryker Orthopaedics-Mahwah; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): Stryker Orthopaedics-Mahwah; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 50223064
• Report Number: 0002249697-2026-00690
• Device Sequence Number: 5445448
• Product Code: KRO
• UDI-Device Identifier: 07613327142525
• UDI-Public: 07613327142525
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K122015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/12/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 6497-1-150
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 17 YR
• Patient Sex: Male
• Patient Weight: 215 LB