MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE FEM STEM CRV 150MM =15>13.5MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number MSSTM-15X150

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problems Unspecified Infection (1930); Insufficient Information (4580)

Event Date 04/07/2021

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 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.Device not returned.

Event Description

The surgeon reported "implanted 10 years ago in the same hospital.Implants concerned: mets distal femur with a rotating pe tibial component.Reason for revision : infection".During the revision, the surgeon discovered a disassociation between the femoral stem and the femoral shaft this mdr is for the femoral stem disassociation.

Manufacturer Narrative

Reported event: an event regarding alleged disassociation and consequent fracture of the alignment lug involving a mets distal femur was reported.The event was confirmed by product inspection.Method & results: -product evaluation and results: visual inspection components of a mets distal femur were received.Visual inspection indicates that the femoral stem is disassociated from the femoral shaft at the taper lock.The alignment lug of the femoral stem taper lock is broken off and part of the alignment lug remains in the taper lock recess of the femoral shaft.Moreover, the surface of the taper junction of the stem shows marked lines.Visual inspection of the other components did not identify any damage or non-conformity relevant to the reported event.Dimensional inspection not performed as not relevant to the reported event.Functional inspection not performed as not relevant to the reported event.Material analysis a material analysis has been performed.The report concluded: visual examination confirmed fracture of the lug on the cemented stem.Stereological and electron microscopy examination identified the stem had rotated which would indicate loss of lock between the cemented stem and the shaft.Disengagement of the stem was identified as a likely contributing factor to the fracture of the lug, the mode of fracture of the lug was not identified due to excessive wear damage of fracture surface.The cause of loss of the initial taper lock is not detectable.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the product history records indicate devices were manufactured with no reported relevant discrepancies.-complaint history review: there have been no other events for the lot referenced.Conclusions: an event regarding alleged disassociation and consequent fracture of the alignment lug involving a mets distal femur was reported.The event was confirmed by product inspection.The material analysis report concluded the disengagement of the stem was identified as a likely contributing factor to the fracture of the lug.However, the mode of fracture of the lug was not identified due to excessive wear damage of fracture surface and the cause of loss of the initial taper lock is not detectable.Thus the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports and progress notes 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

The surgeon reported "implanted 10 years ago in the same hospital.Implants concerned: mets distal femur with a rotating pe tibial component.Reason for revision : infection".During the revision, the surgeon discovered a disassociation between the femoral stem and the femoral shaft this mdr is for the femoral stem disassociation.

• Brand Name: FEM STEM CRV 150MM =15>13.5MM
• 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: 11766448
• MDR Text Key: 252016594
• Report Number: 3004105610-2021-00069
• 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: 09/14/2021

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 Expiration Date: 07/31/2011
• Device Catalogue Number: MSSTM-15X150
• Device Lot Number: B3940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Initial Date Manufacturer Received: 04/07/2021
• Initial Date FDA Received: 05/03/2021
• Supplement Dates Manufacturer Received: 08/26/2021
• Supplement Dates FDA Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention