MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE SMILES MK3 TIBIAL BEARING XSM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number SMMLTBC00

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Ambulation Difficulties (2544)

Event Date 06/03/2022

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

As reported: "dr.Called me today while this patient was in her clinic.She said that he has been subluxing his [right] knee joint.He was able to show her how he could disassociate the tibia from the femur.Patient states that he heard an audible pop (previous to today).She has him in a knee brace and will decide whether to bring him back into surgery to inspect the poly tibial bearing." an email also states the patient is "hyperextending it somehow." and that "the poly bearing in the last photo looks weird.".

Manufacturer Narrative

Reported event: an event regarding loosening involving a jts, distal femoral replacement, tibial bearing 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 jts distal femoral replacement which was inserted on (b)(6)2021.The surgeon reported subluxation and hyperextending of the knee.The x-ray images provided show the femoral and tibial components are aligned properly and the hinge for the knee joint is in place.No subluxation and hyperextending of the knee are observed.However, the tibial component is quite loose and may be able to lift which might be regarded as subluxation by the patient.Therefore, the radiographic review cannot confirm the clinical report.Device history review: review of the product history records indicate devices were 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

As reported: "dr.Called me today while this patient was in her clinic.She said that he has been subluxing his [right] knee joint.He was able to show her how he could disassociate the tibia from the femur.Patient states that he heard an audible pop (previous to today).She has him in a knee brace and will decide whether to bring him back into surgery to inspect the poly tibial bearing." an email also states the patient is "hyperextending it somehow." and that "the poly bearing in the last photo looks weird.".

• Brand Name: SMILES MK3 TIBIAL BEARING XSM
• 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: 14797189
• MDR Text Key: 295039611
• Report Number: 3004105610-2022-00091
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133152
• 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: 08/24/2022

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: SMMLTBC00
• Device Lot Number: B24374
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/03/2022
• Initial Date FDA Received: 06/24/2022
• Supplement Dates Manufacturer Received: 08/18/2022
• Supplement Dates FDA Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2019
• 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; Other; Required Intervention
• Patient Age: 16 YR
• Patient Sex: Male