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

Catalog Number	6497-1-600
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
In following up with the sales rep (intra-operative event), rep responded that the patient underwent a revision surgery on (b)(6) 2017.Revision was due to mechanical failure of the device (locking knob) reported in another report.This report is for the revision on (b)(6) 2017.
Event or Problem Description
In following up with the sales rep (intra-operative event), rep responded that the patient underwent a revision surgery on (b)(6)2017.Revision was due to mechanical failure of the device (locking knob) reported in another report.This report is for the revision on (b)(6)2017.
Additional Manufacturer Narrative
An event regarding revision involving a gmrs femoral component was reported.The event was confirmed by product inspection.Method & results: -product evaluation and results: a material analysis report indicated, ¿"the medial and lateral surfaces of the prosthesis.Damage was observed on the medial surface of the prosthesis, potentially due to the explantation process.Damage was observed on the two screw heads on the lateral surface of the prosthesis.¿ ¿damage was observed on the tip of the screwdrivers and screw heads of the prosthesis.One of the screwdriver tips fractured in the safety screw of the prosthesis.The tip likely prevented the screw from being accessible for tightening and loosening.Damage potentially due to off-axis loading between the screwdrivers and screws were also observed.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined." -clinician review: not performed as medical records were not provided for review.- product history review: a device history review confirmed all devices accepted into finished goods conformed to specification.-complaint history review: no other events were reported for the lot indicated.Conclusions: the investigation concluded that the revision took place as the growing prosthesis could not be extended in a previous procedure.The screw heads on the prosthesis were found to be damaged from off-axis loading.No further investigation for this event is possible at this time as insufficient information was received.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Product surveillance will continue to monitor for trends.

• Brand Name: DISTAL FEMORAL GROWING PROSTHESIS RIGHT 200MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7382886
• Report Number: 0002249697-2018-00918
• Device Sequence Number: 172824
• 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
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2018

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 Expiration Date: 07/31/2021
• Device Catalogue Number: 6497-1-600
• Device Lot Number: K09E301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Initial Date Received by Manufacturer: 12/12/2017
• Supplement Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 03/29/2018
• Supplement Report FDA Received Date: 05/22/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 13 YR