MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DISTAL FEMORAL GROWING PROSTHESIS RIGHT 200MM; KNEE JOINT FEMOROTIBIAL METAL/POLYMER CONSTRAINED CEMENTED PROSTHESIS.

Catalog Number 6497-1-600

Device Problems Mechanical Problem (1384); Mechanical Jam (2983); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Ambulation Difficulties (2544)

Event Date 09/26/2017

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.Remains implanted.

Event Description

It was reported that surgeon was performing a limb-lengthening on the gmrs knee system in patient's right knee.Rep reported there were issues with the smaller 2mm locking screwdriver to unlock the prosthesis.Surgeon attempted to turn the bigger knob to lengthen the patient's leg - the knob turned 1 full turn and locked.As reported by rep: "the locking knob wasn't biting with the driver." the surgeon returned the prosthesis to the baseline state and ended the procedure.Rep reported that the patient will suffer a leg length discrepancy until a solution can be found.The screwdrivers are available for return to stryker, the prosthesis remains implanted in the patient.

Manufacturer Narrative

An event regarding limb length discrepancy involving a distal femoral growing prosthesis right was reported.It was reported that the locking knob wasn't biting with the driver.Based on the provided information, the reported device in this investigation did not contribute to the event.No allegations were made against the distal femoral growing prosthesis therefore it is considered as concomitant.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported that surgeon was performing a limb-lengthening on the gmrs knee system in patient's right knee.Rep reported there were issues with the smaller 2mm locking screwdriver to unlock the prosthesis.Surgeon attempted to turn the bigger knob to lengthen the patient's leg - the knob turned 1 full turn and locked.As reported by rep: "the locking knob wasn't biting with the driver." the surgeon returned the prosthesis to the baseline state and ended the procedure.Rep reported that the patient will suffer a leg length discrepancy until a solution can be found.The screwdrivers are available for return to stryker, the prosthesis remains implanted in the patient.

• Brand Name: DISTAL FEMORAL GROWING PROSTHESIS RIGHT 200MM
• Type of Device: KNEE JOINT FEMOROTIBIAL METAL/POLYMER CONSTRAINED CEMENTED PROSTHESIS.
• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6973888
• MDR Text Key: 90108995
• Report Number: 0002249697-2017-03092
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07613327142631
• UDI-Public: 07613327142631
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2021
• Device Catalogue Number: 6497-1-600
• Device Lot Number: K09E301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2017
• Initial Date FDA Received: 10/24/2017
• Supplement Dates Manufacturer Received: 11/02/2017
• Supplement Dates FDA Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2016
• 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: 12 YR