MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DISTAL FEMORAL GROWING PROSTHESIS RIGHT 180MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 6497-1-580

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 01/04/2023

Event Type  Injury  

Manufacturer Narrative

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 Description

The following was reported: patient¿s growth prosthesis could not be extended as the prosthesis did not unscrew and the screwdriver broke.An additional incision was performed and an extension piece added.

Manufacturer Narrative

Reported event: an event regarding non functional involving a gmrs femoral component was reported.The event was confirmed via clinician review of the provided medical records.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.Clinician review: a review of the provided medical information by a clinical consultant indicated: "both the operative report and final medical report describe a surgical procedure planned for extending a distal femoral growth prosthesis.The extension mechanism is threaded.The surgeon applied the appropriate wrench and attempted to turn the mechanism but was unable to make the prosthesis to extend.He then proceeded to remove the extending mechanism and replaced it with a longer fixed length intercalary segment.The surgeon posited in his operative report that the failure of the extension mechanism was caused by heterotopic bone blocking the threads or deformation of the threads as the patient was an avid soccer player.Inability to extend a previously implanted growing prosthesis is confirmed.The root cause of inability of the prosthesis to extend cannot be determined from this limited amount of documentation." product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the growing prosthesis could not be extended as intended.A review of the provided medical information by a clinical consultant indicated: "both the operative report and final medical report describe a surgical procedure planned for extending a distal femoral growth prosthesis.The extension mechanism is threaded.The surgeon applied the appropriate wrench and attempted to turn the mechanism but was unable to make the prosthesis to extend.He then proceeded to remove the extending mechanism and replaced it with a longer fixed length intercalary segment.The surgeon posited in his operative report that the failure of the extension mechanism was caused by heterotopic bone blocking the threads or deformation of the threads as the patient was an avid soccer player.Inability to extend a previously implanted growing prosthesis is confirmed.The root cause of inability of the prosthesis to extend cannot be determined from this limited amount of documentation." no further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

The following was reported: patient¿s growth prosthesis could not be extended as the prosthesis did not unscrew and the screwdriver broke.An additional incision was performed and an extension piece added.

• Brand Name: DISTAL FEMORAL GROWING PROSTHESIS RIGHT 180MM
• Type of Device: 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 ; 2018315000
• MDR Report Key: 16249901
• MDR Text Key: 308230709
• Report Number: 0002249697-2023-00077
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07613327142617
• UDI-Public: 07613327142617
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K122015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6497-1-580
• Device Catalogue Number: 6497-1-580
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention; Hospitalization
• Patient Age: 14 YR
• Patient Sex: Male
• Patient Weight: 55 KG