MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN_RESTORIS LEFT MEDIAL BASEPLATE; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number UNK_OFL

Device Problems Fracture (1260); Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Pain (1994); Inadequate Osseointegration (2646)

Event Date 08/03/2023

Event Type  Injury  

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.H3 other text : device not returned.

Event Description

As reported in journal (early tibial baseplate fracture after medial unicondylar knee arthroplasty): "presented to our institution with worsening left medial knee pain 1 year after a left medial uka at an outside hospital with a stryker restoris multicompartmental knee system implant, using mako robotic assistance (stryker).He also did well postoperatively, an active person who enjoys walks and hikes.He began experiencing progressively worsening left medial knee pain 2 months before presentation.At the time of evaluation, he was unable to ambulate because of pain.His medical history consisted of hypertension, hyperlipidemia, and benign prostatic hyperplasia (body mass index: 28.5 kg/m2).On examination, he had a well-healed surgical incision without signs of infection.He had exquisite tenderness over the medial proximal tibia and tolerated an arc of motion from 0 to 130°, with pain in deep flexion.Initial postoperative radiographs demonstrated appropriate implant positioning.At the time of our evaluation, radiographs demonstrated significant radiolucency surrounding the tibial baseplate, with a coronally oriented fracture through the baseplate.A computed tomography scan confirmed catastrophic failure of the tibial baseplate with marked loosening of the component.Preoperative workup, including inflammatory markers and knee aspirate, was negative for infection, and he elected to proceed with revision surgery.The femoral component had remained well-fixed, but there was frank subsidence and loosening of the tibial component.There was no evidence of excessive polyethylene wear or damage, and the liner remained locked into the fractured baseplate.There was debonding of the tray from the cement mantle.This was easily removed piecemeal with a rongeur.The knee was not appreciably tight in flexion.Gross retrieval analysis again revealed a coronally oriented fracture through the baseplate without any additional damage to the implant (fig.9).After removal of the remaining cement, a 4 · 4 mm contained defect remained along the medial tibia and was filled with cancellous allograft chips." patient was revised to a competitor knee.Article goes on to state: "it is likely that early cement debonding from the tibial component led to implant cement interface micromotion and subsequent rapid osteolysis beneath the tibial component.".

Event Description

As reported in journal (early tibial baseplate fracture after medial unicondylar knee arthroplasty): ".Presented to our institution with worsening left medial knee pain 1 year after a left medial uka at an outside hospital with a stryker restoris multicompartmental knee system implant, using mako robotic assistance (stryker).He also did well postoperatively, an active person who enjoys walks and hikes.He began experiencing progressively worsening left medial knee pain 2 months before presentation.At the time of evaluation, he was unable to ambulate because of pain.His medical history consisted of hypertension, hyperlipidemia, and benign prostatic hyperplasia (body mass index: 28.5 kg/m2).On examination, he had a well-healed surgical incision without signs of infection.He had exquisite tenderness over the medial proximal tibia and tolerated an arc of motion from 0 to 130°, with pain in deep flexion.Initial postoperative radiographs demonstrated appropriate implant positioning.At the time of our evaluation, radiographs demonstrated significant radiolucency surrounding the tibial baseplate, with a coronally oriented fracture through the baseplate.A computed tomography scan confirmed catastrophic failure of the tibial baseplate with marked loosening of the component.Preoperative workup, including inflammatory markers and knee aspirate, was negative for infection, and he elected to proceed with revision surgery.The femoral component had remained well-fixed, but there was frank subsidence and loosening of the tibial component.There was no evidence of excessive polyethylene wear or damage, and the liner remained locked into the fractured baseplate.There was debonding of the tray from the cement mantle.This was easily removed piecemeal with a rongeur.The knee was not appreciably tight in flexion.Gross retrieval analysis again revealed a coronally oriented fracture through the baseplate without any additional damage to the implant (fig.9).After removal of the remaining cement, a 4 · 4 mm contained defect remained along the medial tibia and was filled with cancellous allograft chips." patient was revised to a competitor knee.Article goes on to state: ".It is likely that early cement debonding from the tibial component led to implant cement interface micromotion and subsequent rapid osteolysis beneath the tibial component.".

Manufacturer Narrative

Reported event: an event regarding loosening, subsidence and crack/fracture involving an unknown baseplate was reported.The event was confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of medical records with a clinical consultant indicated: "conclusion/assessment: no medical records were provided for review.It appears that much of the information provided was obtained from a published manuscript.A unicompartmental left knee was implanted with the mako device.The implant failed less than one year postoperatively.There were osteolytic changes and a fracture of the tibial metallic baseplate.Event confirmation: the event, loosening of a tibial component, can be confirmed.The event, fracture of a tibial baseplate, can be confirmed.The etiology of the loosening cannot be confirmed.Root cause: the root cause of the loosening cannot be ascertained.The root cause of the osteolysis and ultimate fracture of the baseplate was the underlying component loosening." -product history review: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: the patient presented with pain.'initial postoperative radiographs demonstrated appropriate implant positioning.At the time of our evaluation, radiographs demonstrated significant radiolucency surrounding the tibial baseplate, with a coronally oriented fracture through the baseplate.A computed tomography scan confirmed catastrophic failure of the tibial baseplate with marked loosening of the component.Preoperative workup, including inflammatory markers and knee aspirate, was negative for infection, and he elected to proceed with revision surgery.' a review of medical records with a clinical consultant indicated: "conclusion/assessment: no medical records were provided for review.It appears that much of the information provided was obtained from a published manuscript.A unicompartmental left knee was implanted with the mako device.The implant failed less than one year postoperatively.There were osteolytic changes and a fracture of the tibial metallic baseplate.Event confirmation: the event, loosening of a tibial component, can be confirmed.The event, fracture of a tibial baseplate, can be confirmed.The etiology of the loosening cannot be confirmed.Root cause: the root cause of the loosening cannot be ascertained.The root cause of the osteolysis and ultimate fracture of the baseplate was the underlying component loosening.".No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: UNKNOWN_RESTORIS LEFT MEDIAL BASEPLATE
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer (Section G): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer Contact: anna ryan ; raheen business park; limerick, FL NA ; EI NA ; 9546280700
• MDR Report Key: 17648750
• MDR Text Key: 322244217
• Report Number: 3005985723-2023-00129
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_OFL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2023
• 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: 67 YR
• Patient Sex: Male