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
Medical Device Problem Codes	Mechanical Problem (1384); Mechanical Jam (2983); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	09/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.Remains implanted.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: KNEE JOINT FEMOROTIBIAL METAL/POLYMER CONSTRAINED CEMENTED PROSTHESIS.
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6973888
• Report Number: 0002249697-2017-03092
• Device Sequence Number: 518361
• Product Code: KRO
• UDI-Device Identifier: 07613327142631
• UDI-Public: 07613327142631
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 07/06/2021
• Device Catalogue Number: 6497-1-600
• Device Lot Number: K09E301
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/26/2017
• Supplement Date Received by Manufacturer: 11/02/2017
• Initial Report FDA Received Date: 10/24/2017
• Supplement Report FDA Received Date: 12/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 12 YR