MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DISTAL FEMORAL GROWING PROSTHESIS LEFT 150MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	6497-1-150
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Codes	Injury (2348); Ambulation or Postural Difficulties (2544)
Date of Event	06/09/2020
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 relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that the patient's left femur was revised due to the gmrs growing prosthesis no longer expanding (device did not achieve max extension).The surgeon has requested the device be returned for investigation, and is requesting the investigation results.The rep provided the primary and revision usage, and confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding growing prosthesis no longer expanding (non functional) involving a distal femoral growing prosthesis.Method & results: device evaluation and results: item received showed typical signs of use but no significant damages in terms of mishandling.The growing prostheses was extended for approx.35 mm which presents engraved the max of extension.After cleaning the entry of the hexagon screw, it turned out that the internal hexagon was occupied with a broken tip of the corresponding hexagon screwdriver.The returned product had been extended close to its maximum.A broken tip of a hexagon screwdriver avoided screw loosening in order to perform further attempts of extension.The mechanism of the returned growing prosthesis was not affected.Clinician review: no medical records were received for review with a clinical consultant.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: item received showed typical signs of use but no significant damages in terms of mishandling.The growing prostheses was extended for approx.35 mm which presents engraved the max of extension.After cleaning the entry of the hexagon screw, it turned out that the internal hexagon was occupied with a broken tip of the corresponding hexagon screwdriver.The returned product had been extended close to its maximum.A broken tip of a hexagon screwdriver avoided screw loosening in order to perform further attempts of extension.The mechanism of the returned growing prosthesis was not affected.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 the patient's left femur was revised due to the gmrs growing prosthesis no longer expanding (device did not achieve max extension).The surgeon has requested the device be returned for investigation, and is requesting the investigation results.The rep confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: DISTAL FEMORAL 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
• MDR Report Key: 10210686
• Report Number: 0002249697-2020-01324
• Device Sequence Number: 2405287
• Product Code: KRO
• UDI-Device Identifier: 07613327142525
• UDI-Public: 07613327142525
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2020

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 Model Number: 6497-1-150
• Device Catalogue Number: 6497-1-150
• Device Lot Number: K0999FB
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 10/30/2020
• 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: 15 YR