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
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/04/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 0002249697-2023-00077
• Device Sequence Number: 6400524
• Product Code: KRO
• UDI-Device Identifier: 07613327142617
• UDI-Public: 07613327142617
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K122015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2023

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: 6497-1-580
• Device Catalogue Number: 6497-1-580
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2023
• Supplement Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 14 YR
• Patient Sex: Male
• Patient Weight: 55 KG