MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR JTS; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_STM

Device Problem Malposition of Device (2616)

Patient Problems Pain (1994); Injury (2348); Cancer (3262)

Event Date 09/09/2019

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding a distal femur, jts where malposition and maximum extension was reported.The event was confirmed by x- ray review.Methods and results: product evaluation and results: not performed as no items were returned.Clinician review: a review of the provided x ray's by the consulting clinician indicated the following: the implant in situ was for a jts distal femoral replacement which was inserted on the (b)(6) 2012.The surgeon reported that the patient has over grown his implant and the tibia stem is in varus position.The x-ray provided has shown that the implant has been extended by 50mm, which has reached its maximum capacity of 50mm, therefore the implant has served it intended use.It was also noted that the implanted femur is slightly longer than the other side of the femur, but the tibia is much shorter than the opposite side which indicates that the growth plates of the tibia bone has been damaged during the previous surgery.In addition, the tibia stem has tilted towards the lateral side of the bone which caused the knee joint in varus position.Therefore, the radiographic assessment can justify the reason for revision.Device history review: review of the product history records indicate 1 device was manufactured and accepted into final stock on 28 mar 2012 with no reported discrepancies complaint history review: based on the device identification the complaint databases were reviewed from 11-nov-2016 to present for similar reported events regarding jts, distal femur, malposition.There have been 1 other event.Conclusion: the exact cause of the event could not be determined because further information such as retrieval analysis on the explanted device and 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 becomes available to indicate further evaluation is warranted, this record will be re-opened.Catalog numbers and lot codes of other devices listed in this report: smcic01 (b8494) circlip smbsh01 (b8940) bushes smbpr01 (b8941) bumper smtbc01g (b8862) passive grower bearing.Device not returned.

Event Description

On 09sep19: upon investigation of the complaint it was noted that the need of a revision surgery was discovered when the clinician observed progressive knee varus and pain in the lower right limb.

• Brand Name: DISTAL FEMUR JTS
• 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; GB WD6 3SJ
• Manufacturer (Section G): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; GB WD6 3SJ
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; GB WD6 3SJ ; 2082386500
• MDR Report Key: 9400697
• MDR Text Key: 168779464
• Report Number: 3004105610-2019-00124
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K133152
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2013
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 16962
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 19 YR