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

Catalog Number UNK_STM

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Muscular Rigidity (1968); Injury (2348); Cancer (3262)

Event Date 10/08/2018

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.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Device not returned.

Event Description

It is reported that " [a] revision of pin 19235 due to muscle contracture." additionally, " the surgeon asks for the designers team decision for this case." note - on 24sep19 during the investigation for (b)(4) (mdr reference number 3004105610-2019- 00106) it was noted that the patient had a previous revision that was not logged and investigated.Therefore this (b)(4), has been logged to retrospectively investigate and report the revision that occurred for pin 19235 due to muscle contracture.

Manufacturer Narrative

Reported event: an event regarding patient factors, muscle contracture involving a proximal tibia, femoral component was reported.The event was not confirmed by medical review.Method & results: device evaluation and results: not performed as product was not returned.A review of the provided x-rays by a clinical consultant indicated: the implant in situ was for a jts proximal tibia replacement, which was inserted on (b)(6) 2015.The surgeon reported a muscle contracture of the knee joint.The ct scans provided show that the left knee is in flexion which could have been caused by the muscle contracture, but this cannot be confirmed by the radiographic assessment.Device history review: review of the product history records indicate 1 device was manufactured and accepted into final stock on 06 mar 2015 with no reported discrepancies complaint history review: based on the device identification the complaint databases were reviewed from 01-jan-2016 to present for similar reported events regarding proximal tibia, femoral component, patient factors (related to muscle / contracture).There has been no other events.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, mri scans 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

It is reported that " [a] revision of pin: 19235 due to muscle contracture." additionally, " the surgeon asks for the designers team decision for this case".Note: on 24sep19, during the investigation for (b)(4) (mdr reference number; 3004105610-2019-00106) it was noted that the patient had a previous revision that was not logged and investigated.Therefore this (b)(4), has been logged to retrospectively investigate and report the revision that occurred for pin 19235 due to muscle contracture.

• Brand Name: PROXIMAL TIBIA 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
• MDR Report Key: 9224889
• MDR Text Key: 170793183
• Report Number: 3004105610-2019-00114
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K092138
• 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: 01/30/2020

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: Lay User/Patient
• Device Expiration Date: 09/30/2015
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 19235
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/24/2019
• Initial Date FDA Received: 10/23/2019
• Supplement Dates Manufacturer Received: 01/21/2020
• Supplement Dates FDA Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 12 YR