MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN_RIGHT MAKO UNI KNEE; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY

Catalog Number UNK_OFL

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 04/25/2017

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

This is for revision of the patient's right knee on (b)(6) 2017.It was reported that: revision of patient's right knee on (b)(6) 2024, rep provided an op report for (b)(6) 2017 in which a uni knee was revised to a total knee.Preop diagnosis was 'right knee failed unicompartment arthroplasty.' rep confirmed the revised uni knee was a mako knee.No further information about the revision is available from the hospital or surgeon.

Event Description

This is for revision of the patient's right knee on (b)(6) 2017.It was reported that: revision of patient's right knee on (b)(6) 2024), rep provided an op report for (b)(6) 2017 in which a uni knee was revised to a total knee.Preop diagnosis was 'right knee failed unicompartment arthroplasty.' rep confirmed the revised uni knee was a mako knee.No further information about the revision is available from the hospital or surgeon.

Manufacturer Narrative

Reported event: an event regarding revision involving an unknown mako knee was reported.The event was not 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: cap this patient underwent an initial unicompartmental arthroplasty which failed in 2017.A revision was carried out in 2024.I can confirm that the patient underwent the revision in 2017 since i was able to see an operation report indicating revision surgery.I cannot confirm the revision in 2024 since i have no documentation such as operation reports, doctors notes or any x-rays.The root cause of failure of a unicompartmental knee replacement in this case cannot be determined with certainty.In the operation note for the revision there was no mention of what the pathology was and what condition he was correcting.In general the causes of multifactorial including surgical technique, indication, patient activity level and bmi.Unless the implant failure was for breakage or polyethylene wear, i would not implicate the prosthesis as a causative factor.Regarding revision for a loose femoral component, the root cause again in this case cannot be determined with certainty.No x-rays were provided or any office notes.Causes of femoral loosening of the cemented component include surgical technique especially in the manner of implantation and cement procedure.Causes also include patient factors such as activity level and bmi.Unless there is a breakage of the component, i would not assign any causality to the component itself unless evidence was provided to the contrary.Any explanted prosthesis should be submitted to stryker engineers for evaluation and analysis.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 exact cause of the event could not be determined because insufficient information was provided.Medical records were received for review with a clinical consultant: "cap this patient underwent an initial unicompartmental arthroplasty which failed in 2017.A revision was carried out in 2024.I can confirm that the patient underwent the revision in 2017 since i was able to see an operation report indicating revision surgery.I cannot confirm the revision in 2024 since i have no documentation such as operation reports, doctors notes or any x-rays.The root cause of failure of a unicompartmental knee replacement in this case cannot be determined with certainty.In the operation note for the revision there was no mention of what the pathology was and what condition he was correcting.In general the causes of multifactorial including surgical technique, indication, patient activity level and bmi.Unless the implant failure was for breakage or polyethylene wear, i would not implicate the prosthesis as a causative factor.Regarding revision for a loose femoral component, the root cause again in this case cannot be determined with certainty.No x-rays were provided or any office notes.Causes of femoral loosening of the cemented component include surgical technique especially in the manner of implantation and cement procedure.Causes also include patient factors such as activity level and bmi.Unless there is a breakage of the component, i would not assign any causality to the component itself unless evidence was provided to the contrary.Any explanted prosthesis should be submitted to stryker engineers for evaluation and analysis." further information such as pathology reports, pre- and post-operative x-rays and the operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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.H3 other text: device not returned to the manufacturer.

• Brand Name: UNKNOWN_RIGHT MAKO UNI KNEE
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY
• 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: sanjana talathi ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18779670
• MDR Text Key: 336236636
• Report Number: 3005985723-2024-00026
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: UNK_OFL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: No
• 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: 56 YR
• Patient Sex: Female