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

Catalog Number UNK_STM

Device Problem Loss of Osseointegration (2408)

Patient Problems Injury (2348); Inadequate Osseointegration (2646); Cancer (3262)

Event Date 03/12/2020

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.Device not returned.

Event Description

A patient specific implant prescription form has been received: patient has an impending revision due to patient's left, proximal tibial component loosening.

Manufacturer Narrative

Reported event: an event regarding alleged loosening involving the tibial component of a patient specific distal femoral replacement was reported.The event was confirmed by x-ray review.Method and results: product evaluation and results: not performed as device was not returned.Clinician review: the implant in situ was for a patient specific distal femoral replacement in which the tibial component was inserted in 1986.The surgeon reported an aseptic loosening of the tibial stem.The ct image provided showed gross radiolucent line along the stem between the cemented mantle and the bone, and between the stem and the cement mantle, which indicate that the tibial stem has loosened.Therefore, the radiographic review can confirm the reason for revision.Product history review: a review of the siw company intranet confirms that the implant was released on 20feb1986 and implanted on 22feb1986.Complaint history review: there have been 2 other events.Conclusions: an event regarding alleged loosening involving the tibial component of a patient specific distal femoral replacement was reported.The event was confirmed by x-ray review.The implant remained in situ for more than 30 years.The exact cause of the event could not be determined because further information such as pre- and post-operative x-rays 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/or insufficient information was received by siw.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be re-opened.

Event Description

A patient specific implant prescription form has been received: patient has an impending revision due to patient's left, proximal tibial component loosening.

• Brand Name: DISTAL FEMORAL REPLACEMENT
• 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: 9942390
• MDR Text Key: 188058480
• Report Number: 3004105610-2020-00083
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K140898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/23/2020

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: Health Professional
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 831
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2020
• Initial Date FDA Received: 04/09/2020
• Supplement Dates Manufacturer Received: 08/28/2020
• Supplement Dates FDA Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR