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

Catalog Number UNK_STM

Device Problem Loss of Osseointegration (2408)

Patient Problem Inadequate Osseointegration (2646)

Event Date 01/21/2022

Event Type  Injury  

Event Description

A patient specific prescription form has been received for a revision - "likely aseptic loosening".Update 08 april 2022: clinician review found the following: "the x-ray images provided show radiolucent lines along the femoral and tibial stems, mainly between the cement mantle and bone, suggesting aseptic loosening of the stem".

Manufacturer Narrative

The reported device is similar to a device approved for compassionate use in the united states.Reported event: an event regarding loosening involving a patient specific, proximal tibial replacement, tibial stem was reported.The event was confirmed by x ray review.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 patient specific proximal tibial replacement which was inserted on (b)(6) 1999 and the tibial component was revised on (b)(6) 2014.The surgeon reported "likely aseptic loosening".The x-ray images provided show radiolucent lines along the femoral and tibial stems, mainly between the cement mantle and bone, suggesting aseptic loosening of the stem.The femoral and tibial bone have undergone remodelling and resorption, left a very thin cortex.Therefore, the radiographic review can confirm the clinical report.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 relevant 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.

• Brand Name: PROXIMAL TIBIAL REPLACEMENT - 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 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: 14110678
• MDR Text Key: 289250487
• Report Number: 3004105610-2022-00058
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2014
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 18581
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2014
• 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: 36 YR
• Patient Sex: Male