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

Catalog Number UNK_STM

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Injury (2348); Insufficient Information (4580)

Event Date 08/12/2020

Event Type  Injury  

Manufacturer Narrative

An investigation is being performed in an attempt to identify the cause of the event.Should additional information become available it will be reported in a supplemental report.Device not returned.

Event Description

A patient specific implant prescription form was received for the revision of a right distal femoral mets implant with notes: "failure of mets prosthesis - taper junction.Silver coated.Monoblock please as very heavy patient.".

Manufacturer Narrative

An event regarding disassociation involving a mets distal femur replacement, femoral component 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 mets distal femoral replacement, the date of insertion was in 2012.The surgeon reported a failure of the taper junction.The ct scan provided shows that the femoral implant has been rotated which indicate that the taper junction between the femoral shaft within the femoral component has disengaged.However, this disengagement of the taper junction can not be observed radiographically.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 specific implant prescription form was received for the revision of a right distal femoral mets implant with notes: "failure of mets prosthesis - taper junction, silver coated.Monoblock please as very heavy patient.".

• Brand Name: UNKNOWN METS DISTAL FEMORAL REPLACEMENT - FEMORAL COMPONENT
• 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: 10501875
• MDR Text Key: 205912483
• Report Number: 3004105610-2020-00140
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K121029
• 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: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• 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
• Date Manufacturer Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 36 YR