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

Catalog Number UNK_OFL

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

Patient Problems Fall (1848); Pain (1994)

Event Date 10/13/2021

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.Device not returned.

Event Description

The trial manager reported that the patient who had been implanted with a mako knee, called to complete 3 month (b)(6) clinical trial visit.On the call patient explained he had been for a walk and felt something pop.Since then patient has been having pain and discomfort to operated leg from his knee down to calf.The patient had urgent review, following this appointment patient sent for a ultrasound scan.Results are awaited.

Event Description

The trial manager reported that the patient who had been implanted with a mako knee, called to complete 3 month racer clinical trial visit.On the call patient explained he had been for a walk and felt something pop.Since then patient has been having pain and discomfort to operated leg from his knee down to calf.The patient had urgent review, following this appointment patient sent for a ultrasound scan.

Manufacturer Narrative

Reported event: an event regarding revision due to pain involving an unknown mako knee was reported.The event was not confirmed.Method & results:  -device evaluation and results: not performed as product was not returned.-clinician review: no medical records were received for review with a clinical consultant   -device history review: could not be performed as lot code information was not provided.  -complaint history review: could not be performed as lot code information was not provided.  conclusion: the event itself could not be confirmed and exact cause of the event could not be determined because insufficient information was provided.Further information such as device return, pre and post operative x-rays, operative reports as well as patient history and follow up notes are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not returned.

• Brand Name: UNKNOWN MAKO KNEE
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: alessandra chavez ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 12773371
• MDR Text Key: 280599488
• Report Number: 3005985723-2021-00180
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_OFL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2021
• 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): Hospitalization; Required Intervention