MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR JTS; LIMB SALVAGE SYSTEM

Catalog Number UNK_STM

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 09/17/2018

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 available.

Event Description

It was reported that the patient was walking, lost control of his leg, and fell.X-rays indicate the hinge of the patient's knee construct broke.A revision has not yet been performed but is being planned to exchange the tibial component.Femoral component reported as well-fixed and will not be revised due to any allegations against the device.

Event Description

It was reported that the patient was walking, lost control of his leg, and fell.X-rays indicate the hinge of the patient's knee construct broke.A revision has not yet been performed but is being planned to exchange the tibial component.Femoral component reported as well-fixed and will not be revised due to any allegations against the device.

Manufacturer Narrative

Corrected data: device name was corrected from distal femur to distal femur jts.Pma 510(k) # was corrected from k140898 to k133152.Additional manufacture narrative: an event regarding alleged fracture of the tibial hinge involving a jts distal femur was reported.The event was confirmed by medical review.Method and results: product evaluation and results: not performed as no items were returned.Clinician review: the implant in situ was for a jts distal femoral replacement which was inserted on (b)(6) 2011.The surgeon reported that the patient had a fall and the knee hinge has broken.The medical imaging provided shows that the tibial part of the hinge has fractured, and the knee joint has dislocated.The femoral stem has moved anteriorly, especially when the knee is in flexion.The above radiographic assessment has confirmed the reason for revision.Product history review: review of the product history records indicate one device was manufactured and accepted into final stock on 18 aug 2011 with no reported discrepancies.Complaint history review: there have been no other events.Conclusions: following a patient fall the tibial hinge was reported to have fractured and the surgeon reported that the axle cap was removed from its place, the surgeon does not know if the disassociation of the axle cap occurred when the implant was broken or before.The exact cause of the event could not be determined because further information such as device return, the primary operative report as well as patient history and follow up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as no devices and insufficient information was received by siw.If devices and additional information become available to indicate further evaluation is warranted, this record will be re-opened.Revision surgery took place on (b)(6) 2018 due to fractured tibial hinge whereby jts distal femur components were explanted.Siw will continue to monitor for trends.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.

• Brand Name: DISTAL FEMUR JTS
• Type of Device: LIMB SALVAGE SYSTEM
• Manufacturer (Section D): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; GB WD6 3SJ
• MDR Report Key: 7964677
• MDR Text Key: 123675034
• Report Number: 3004105610-2018-00098
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K133152
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2012
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 16331
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SMBPR00 SMILES KNEE BUMPERS EXSM B7775; SMBSH00 SMILES KNEE BUSHES EXSMALL B7776; SMCAP01 AXLE CAP B8537; SMTBC00G PASSIVE GROWER TIB BEARING XSM B8462
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 18 YR