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

Catalog Number UNK_STM

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problem Insufficient Information (4580)

Event Date 03/13/2023

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.Device remains implanted.

Event Description

The following was reported: i am following this patient who was operated on in (b)(6) 2012 for a proximal tibia.He has wear of his axis/bearing and a circlip that has been mobile but not moving for a few years.I want to change the minimum because the bone is not engaging.

Event Description

The following was reported: i am following this patient who was operated on in (b)(6) 2012 for a proximal tibia.He has wear of his axis/bearing and a circlip that has been mobile but not moving for a few years.I want to change the minimum because the bone is not engaging.Update as per x ray review (b)(6) 2023: " the only front view of the x-ray image provided showed the femoral component was in line and engaged with the tibial component [.] however, the circlip was backed out on the medial side indicating loosening of the axle.Therefore, the radiographic review can confirm the clinical report and reason for revision".

Manufacturer Narrative

Reported event: an event regarding disassociation involving a mets, proximal tibia replacement, axle was reported.The event was confirmed by x ray review.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 mets proximal tibial replacement which was inserted in (b)(6) 2012.The surgeon reported wear of the axle/bearing and loosening of the circlip.The only front view of the x-ray image provided showed the femoral component was in line and engaged with the tibial component.The gap between the femoral and tibial components was reasonably even but considering that the implant has been in situ for over 10 years, normal wear and tear is expected.However, the circlip was backed out on the medial side indicating loosening of the axle.Therefore, the radiographic review can confirm the clinical report and reason for revision.Device history review: a review of the product history records could not be performed as the lot / batch information was not provided.Complaint history review: a complaint history review could not be performed as the lot / batch information was not provided.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, additional x-rays 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: METS PROXIMAL TIBIAL REPLACEMENT - AXLE
• 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, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 16674461
• MDR Text Key: 312617186
• Report Number: 3004105610-2023-00037
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 05/05/2023

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: Health Professional
• Device Catalogue Number: UNK_STM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2023
• Initial Date FDA Received: 04/04/2023
• Supplement Dates Manufacturer Received: 04/27/2023
• Supplement Dates FDA Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 20 YR
• Patient Sex: Male