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

Catalog Number UNK_STM

Device Problem Naturally Worn (2988)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/27/2022

Event Type  Injury  

Event Description

A patient specific prescription form has been received for "prox tibial mark 3 bearing for re-bushing".Additional notes on the form - previous revision of diaphyseal to proximal tibia, now needs re-bushing for custom bushings.

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.

Manufacturer Narrative

Reported event: an event regarding rebushing involving a patient specific, proximal tibial, tibial bearing.Was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided x-rays by a clinical consultant indicated: the implant in situ was for proximal tibial replacement which was inserted on (b)(6) 2003.The surgeon required re-bushing of the knee.The x-ray provided shows the implant is well aligned and fixed.No clear signs of wear from the images but considering the duration of the device in situ, it is reasonable to perform rebushing of the knee.Device history review: review of the product history records indicate the device was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.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

A patient specific prescription form has been received for "prox tibial mark 3 bearing for re-bushing".Additional notes on the form - previous revision of diaphyseal to proximal tibia, now needs re-bushing for custom bushings.

• Brand Name: PROXIMAL TIBIA - TIBIAL BEARING
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 14754807
• MDR Text Key: 294404946
• Report Number: 3004105610-2022-00089
• 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: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2004
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 10183
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2003
• 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: 56 YR