MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE UNKNOWN METS FEMORAL HEAD; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_STM

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Joint Laxity (4526); Unequal Limb Length (4534)

Event Date 12/29/2020

Event Type  Injury  

Manufacturer Narrative

An investigation is being performed in an attempt to identify the cause of the event.Not returned to the manufacturer.

Event Description

A patient specific prescription form was received for the patient's left proximal femur minimally invasive grower.Noted on the form: "reason for surgery: max extension, limb length discrepancy.Limb length discrepancy ~40mm.Reduce the angle of inclination." x-ray review states "there is a subluxation of the hip and the hip joint is in varus deformity.".

Manufacturer Narrative

Reported event: an event regarding subluxation involving a mig, proximal femur, femoral head, was reported.The event was confirmed by x ray review.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided x-rays by a clinical consultant indicated: the implant in situ was for a mig proximal femoral replacement which was inserted in 2019.The surgeon reported that the implant has achieved maximum extension.It was also reported leg length discrepancy (40mm) and reduced angle of inclination.The ct scan provided shows that the implant has been extended by 50mm which has reached to its maximum capacity of 53mm.The affected femur is 43mm shorter than the opposite femur.There is a subluxation of the hip and the hip joint is in varus deformity.The radiographic observation can confirm part of the clinical reports and reasons for revision.Device history review: a review of the product history records could not be performed as the lot / batch information was not provided.Complaint history review: a complaint history review could not be performed as the lot / batch information was not provided.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's specific prescription form was received for the patient's left proximal femur minimally invasive grower.Noted on the form: "reason for surgery: max extension, limb length discrepancy.Limb length discrepancy ~40mm.Reduce the angle of inclination." x-ray review states "there is a subluxation of the hip and the hip joint is in varus deformity.".

• Brand Name: UNKNOWN METS FEMORAL HEAD
• 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
• MDR Report Key: 11490925
• MDR Text Key: 240044161
• Report Number: 3004105610-2021-00038
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 04/09/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_STM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2021
• Initial Date FDA Received: 03/16/2021
• Supplement Dates Manufacturer Received: 04/08/2021
• Supplement Dates FDA Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 9 YR