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

Catalog Number UNK_STM

Device Problems Unstable (1667); Osseointegration Problem (3003)

Patient Problems Ambulation Difficulties (2544); Inadequate Osseointegration (2646)

Event Date 12/28/2020

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.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.Not available.

Event Description

A patient specific prescription form for the patient's right proximal tibia jts was received.Noted on the form: "reason for surgery: max extension, tibial stem instability.Save femoral component.10mm of extension will be realized before the surgery.

Event Description

A patient specific prescription form for the patient's right proximal tibia jts was received.Noted on the form: "reason for surgery: max extension, tibial stem instability.Save femoral component.10mm of extension will be realized before the surgery.(b)(6) 2021: during case review, it was confirmed that the reason for the tibial stem instability is loosening.

Manufacturer Narrative

Reported event: an event regarding loosening involving a jts proximal tibia was reported.The event was confirmed by medical review.Method & results: product evaluation and results: not performed as no items were returned.Clinician review: medical review confirmed the loosening of the tibial stem, which resulted also in instability and malposition.Product history review: review of the product history records indicate the device was manufactured and accepted into final stock with no reported relevant discrepancies complaint history review: there have been no other events for the pin referenced.Conclusions: an event regarding loosening involving a jts proximal tibia was reported.The event was confirmed by medical review.The exact cause of the event could not be determined because further information such as 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/or insufficient information was received by stryker orthopaedics.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: PROXIMAL TIBIA JTS - TIBIAL STEM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood NJ WD6 3 SJ; UK WD6 3SJ
• MDR Report Key: 11170272
• MDR Text Key: 226801617
• Report Number: 3004105610-2021-00010
• 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: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 21573
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 8 YR