MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE TIB.CAS. ASSY SMALL SHORT STEM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number MKRHM-SMST

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 01/09/2023

Event Type  Injury  

Manufacturer Narrative

An investigation is being performed in an attempt to identify the cause of the event.Should additional information become available it will be reported in a supplemental report.

Event Description

It was reported that : recent mets distal femur placement: rotational hinge decoupling as mentioned below in the weekend.No specific activity leading to this situation other than instability mentioned below.Initial op on (b)(6) 2022.Implants placed: mscol-r30c / mkrhm-smst / msstm-13x150 / mkfe-rsm / msfshft-105.Implant involved in the incident: mkrhm-smst.The patient's situation on arrival at the hospital: extensive washing of the surgical site, then further reduction of the implant while waiting to change the tibial component.The patient wears a competitor splint to prevent flexion."the evolution was however good with impeccable healing and increasingly minimal pain.According to the patient, from the beginning, she has strange sensations with the impression of decoaptation (mobile part of the tibia probably) particularly annoying in this patient who has almost no extensor device and must swing her leg to pass the step.Slipping into bed, complete de-aptation of the tibial keel which has also crossed the knee.The patient was able to be operated urgently, the keel jumps to 100 ¿ 110 ° of flexion under ag despite the absence of shortening.".

Manufacturer Narrative

Reported event: an event regarding instability and infection involving a mets, distal femoral replacement, tibial component 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 concern was for mets rotating hinge distal femoral replacement which was inserted in (b)(6) 2022.The surgeon reported instability of the knee and infection.The patient had no extensor muscle thus swung the leg while walking.Only one plain x-ray image (no date, no side) was available which only showed tibial stem and knee joint, but the medical and surgical description were presented.The patient had medical history of chronic staphylococcus epidermidis infection at 11 years of a third massive right knee prosthesis with recurrent and acute episode which led to this one-stage revision knee surgery.During surgery, it was found both the femoral and tibial stems were well fixed.The x-ray image showed small radiolucent lines along the tibial stem between the cement mantle and bone, this may not cause loosening of the stem yet.My impression is that the clinical symptoms of the knee function and recurrent infection are rather likely related to the patient¿s particular conditions than the implant itself.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.Sterile lot: 2203-3052a there have been no other events for the sterile lot referenced conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, additional x ray images, 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.The following devices were also listed in this report: col rnd.Ø=30mm s/collar ha; cat # mscol-r30c; lot # b31550 femoral shaft.L= 105mm; cat # msfshft-105; lot # b25577 fem stem crv 150mm ø=13>11.5mm; cat # msstm-13x150; lot # b25469 fem knee w/epi r sm; cat # mkfe-rsm; lot # a32723 it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

It was reported that : recent mets distal femur placement: rotational hinge decoupling as mentioned below in the weekend no specific activity leading to this situation other than instability mentioned below.Initial op on (b)(6) 2022 implants placed: mscol-r30c / mkrhm-smst / msstm-13x150 / mkfe-rsm / msfshft-105 implant involved in the incident: mkrhm-smst the patient's situation on arrival at the hospital: extensive washing of the surgical site, then further reduction of the implant while waiting to change the tibial component.The patient wears a competitor splint to prevent flexion."the evolution was however good with impeccable healing and increasingly minimal pain.According to the patient, from the beginning, she has strange sensations with the impression of decoaptation (mobile part of the tibia probably) particularly annoying in this patient who has almost no extensor device and must swing her leg to pass the step.Slipping into bed, complete de-aptation of the tibial keel which has also crossed the knee.The patient was able to be operated urgently, the keel jumps to 100 ¿ 110 ° of flexion under ag despite the absence of shortening." review of medical records by clinician confirmed the following: " [.] my impression is that the clinical symptoms of the knee function and recurrent infection are rather likely related to the patient¿s particular conditions than the implant itself".

• Brand Name: TIB.CAS. ASSY SMALL SHORT 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, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 16202379
• MDR Text Key: 307657983
• Report Number: 3004105610-2023-00006
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K121029
• 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: 04/20/2023

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: MKRHM-SMST
• Device Lot Number: A32560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2023
• Initial Date FDA Received: 01/19/2023
• Supplement Dates Manufacturer Received: 03/24/2023
• Supplement Dates FDA Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2021
• 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: 47 YR
• Patient Sex: Female
• Patient Weight: 85 KG