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

Catalog Number UNK_STM

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Ambulation Difficulties (2544)

Event Date 06/26/2023

Event Type  Injury  

Manufacturer Narrative

The reported device is similar to a device approved for compassionate use in the united states.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.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.H3 other text : device remains implanted.

Event Description

As reported: "this lady had this custom, joint sparing diaphyseal replacement.The junction has failed.Both components are osseo-integrated." right tibia.

Manufacturer Narrative

Reported event: an event regarding disassociation involving a midshaft tibia replacement, tibial component was reported.The event was confirmed via clinician review of the provided x-ray images.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.-clinician review: a review of the provided x-rays by clinical consultant indicated: "this patient underwent a custom articular sparing diaphyseal replacement of the tibia.Approximately 19 years later one of the components of the implant has failed.Although no revision was mentioned this will most likely be necessary.I can confirm that the patient had this custom prosthesis since i was able to see the x-ray.I do see a small abnormality on lateral view but i cannot confirm exactly what part has failed.The root cause of this event cannot be determined with absolute certainty.The causes of mechanical failure of a mega/replacement prosthesis are multifactorial including surgical technique and assembly, patient factors including activity level and bmi, and implant factors.Failure of this type of implant 19 years after implantation in a young patient would not be an unusual phenomenon." -product history review: review of the product history records indicate device was manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient is planned to be revised due to disassociation of the custom midshaft tibia.A review of the provided x-rays by clinical consultant indicated: "this patient underwent a custom articular sparing diaphyseal replacement of the tibia.Approximately 19 years later one of the components of the implant has failed.Although no revision was mentioned this will most likely be necessary.I can confirm that the patient had this custom prosthesis since i was able to see the x-ray.I do see a small abnormality on lateral view but i cannot confirm exactly what part has failed.The root cause of this event cannot be determined with absolute certainty.The causes of mechanical failure of a mega/replacement prosthesis are multifactorial including surgical technique and assembly, patient factors including activity level and bmi, and implant factors.Failure of this type of implant 19 years after implantation in a young patient would not be an unusual phenomenon." additional information including operative reports, pathology reports, progress notes, 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

As reported: "this lady had this custom, joint sparing diaphyseal replacement.The junction has failed.Both components are osseo-integrated." right tibia.

• Brand Name: TIBIAL DIAPHYSEAL 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
• Manufacturer (Section G): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; UK WD6 3SJ
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17348252
• MDR Text Key: 319379378
• Report Number: 3004105610-2023-00067
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/16/2023

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: 06/30/2005
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 11236
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2023
• Initial Date FDA Received: 07/19/2023
• Supplement Dates Manufacturer Received: 09/22/2023
• Supplement Dates FDA Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2004
• 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): Required Intervention; Hospitalization
• Patient Age: 42 YR
• Patient Sex: Female