MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR MINIMALLY INVASIVE GROWER (MIG) - PISTON; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_STM

Device Problems Fracture (1260); Use of Device Problem (1670)

Patient Problems Pain (1994); Ambulation Difficulties (2544); Unequal Limb Length (4534)

Event Date 01/03/2023

Event Type  Injury  

Manufacturer Narrative

The reported device is similar to a device approved for compassionate use in the united states.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 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.

Event Description

A patient specific implant request form was received for revision of the patient's right diaphyseal femoral mig.Noted on the form: "fracture the telescopic rod of the extendable joint saver." additional information provided by surgeon: the patient was well from 2021 until 2022.He has been practicing rock climbing in australia for a year.He felt some thigh pain when standing from a sitting position.Also, some decrease knee flexion movement.The patient is still walking on this broken threaded rod inside the telescopic shaft (now only 1cm overlapping), there is great concern about further metal wear and the two parts may disassemble.".

Manufacturer Narrative

An event regarding crack/fracture & user error involving a mig, midshaft femoral replacement was reported.The event was confirmed by x ray review.Device evaluation and results: not performed as product was not returned.Clinician review: the implant in situ was for mig diaphyseal femoral replacement which was inserted in (b)(6) 2009.The surgeon reported fracture of the telescopic rod of the extendable joint saver.The ct image provided showed that the piston was broken inside the telescoping shaft which supports the clinical report.In addition, it was noted that the implant has been extended by 89mm which is over its maximum capacity of 70mm.This may cause the remaining piston inside the telescoping shaft to be too short and become unstable.Therefore, the radiographic review can confirm the reason for revision.Device history review: review of the product history records indicate the device was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, pathology reports, progress notes and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

A patient specific implant request form was received for revision of the patient's right diaphyseal femoral mig.Noted on the form: "fracture the telescopic rod of the extendable joint saver." additional information provided by surgeon: the patient was well from 2021 until 2022.He has been practicing rock climbing in australia for a year.He felt some thigh pain when standing from a sitting position.Also, some decrease knee flexion movement.The patient is still walking on this broken threaded rod inside the telescopic shaft (now only 1cm overlapping), there is great concern about further metal wear and the two parts may disassemble." update: 29jan2023: "the patient was admitted to the hospital yesterday as the broken shaft dislodged and displaced.There is skin impingement now." update 28feb2023: x-ray review stated the following: " in addition, it was noted that the implant has been extended by 89mm which is over its maximum capacity of 70mm.This may cause the remaining piston inside the telescoping shaft too short and become unstable".

• Brand Name: DISTAL FEMUR MINIMALLY INVASIVE GROWER (MIG) - PISTON
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; UK WD6 3SJ
• Manufacturer (Section G): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; UK WD6 3SJ
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 16226804
• MDR Text Key: 307934218
• Report Number: 3004105610-2023-00008
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2009
• Device Catalogue Number: UNK_STM
• Device Lot Number: PI 14502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2009
• 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: 20 YR
• Patient Sex: Male