MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 4 - 8 MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180734-1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Unspecified Infection (1930); Pain (1994); Inadequate Osseointegration (2646)

Event Date 12/27/2019

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.

Event Description

As per patient's voicemail: patient stated he had a tka on (b)(6) 2019.Patient stated he is unable to walk.Update as per patient: patient stated he had a pka on (b)(6) 2019.Patient was taken to the recovery room and was told he had to see a pt.He asked the nurse to use the bathroom because he couldn't get out of bed, he was told he couldn't use the bathroom as he had to do pt first.The patient asked for a percocet for pain and he was told he couldn't get one until after pt.The physical therapist also told him that he couldn't use the restroom until he had pt.The physical therapist assisted him to the bathroom after pt was done.While the physical therapist was assisting, he let go of the gate belt and the patient fell on the leg that was operated on.The physical therapist assisted the patient to the bed and told the patient that he was going to report the fall and get in touch with the physicians assistant.1-2 hours later the physician assistants came to check on the patient and the patient told them of the fall.The physicians checked the wound and the patient was discharged.The patient was told if he experiences any symptoms to call them.Patient stated that his wife was present and witness the whole incident.The next day the patient got up to use the bathroom and heard a pop.His wife called the surgeons office and was told that the popping was due to scar tissue.1-2 days after the patient was home from surgery he called the surgeon as he was experiencing excruciating pain he felt as his leg was on fire.The patient was prescribed percocet.2-3 days later the patient was still experiencing excruciating patient his wife took him to a walk-in emergence clinic.He was given an x-ray and was told that he might have an infection and was prescribed antibiotics and pain medication.12 days later he saw his surgeon.The patient stated the surgeon was upset at him as he was on a walker.The surgeon did an x-ray and told the patient that it looked good.His wife told the surgeon that the reason he was using the walker was because of the fall but the surgeon told them that it wasn't that every patient is different some take longer than others.The patient was told to come back in 8 weeks for a follow up.Patient was on pt for about two months.On (b)(6) 2020 the patient went to another surgeon for a second opinion and the surgeon performed an mri and told the patient there's a possible loosening of component that's causing his symptoms.The surgeon recommended revision surgery.The patient lost his job, 6 weeks vacation and insurance.Patient would like to also know why our ct micro scan guidelines weren't used appropriately.The patient stated that per guidelines you need 1-2 weeks prior to surgery and he was only given 2 hrs.The patient is seeking compensation for all his loss and pain.

Manufacturer Narrative

Upon additional information received, it was discovered that the device reported in this event belongs to a different registration.A new mdr has been filled under mfr# 3005985723-2022-00021.Investigation results and conclusions will continue using the aforementioned mfr.

Event Description

As per patient's voicemail: patient stated he had a tka on (b)(6) 2019.Patient stated he is unable to walk.Update as per patient: patient stated he had a pka on (b)(6) 2019.Patient was taken to the recovery room and was told he had to see a pt.He asked the nurse to use the bathroom because he couldn't get out of bed, he was told he couldn't use the bathroom as he had to do pt first.The patient asked for a percocet for pain and he was told he couldn't get one until after pt.The physical therapist also told him that he couldn't use the restroom until he had pt.The physical therapist assisted him to the bathroom after pt was done.While the physical therapist was assisting, he let go of the gate belt and the patient fell on the leg that was operated on.The physical therapist assisted the patient to the bed and told the patient that he was going to report the fall and get in touch with the physicians assistant.1-2 hours later the physician assistants came to check on the patient and the patient told them of the fall.The physicians checked the wound and the patient was discharged.The patient was told if he experiences any symptoms to call them.Patient stated that his wife was present and witness the whole incident.The next day the patient got up to use the bathroom and heard a pop.His wife called the surgeons office and was told that the popping was due to scar tissue.1-2 days after the patient was home from surgery he called the surgeon as he was experiencing excruciating pain he felt as his leg was on fire.The patient was prescribed percocet.2-3 days later the patient was still experiencing excruciating patient his wife took him to a walk-in emergence clinic.He was given an x-ray and was told that he might have an infection and was prescribed antibiotics and pain medication.12 days later he saw his surgeon.The patient stated the surgeon was upset at him as he was on a walker.The surgeon did an x-ray and told the patient that it looked good.His wife told the surgeon that the reason he was using the walker was because of the fall but the surgeon told them that it wasn't that every patient is different some take longer than others.The patient was told to come back in 8 weeks for a follow up.Patient was on pt for about two months.On (b)(6) 2020 the patient went to another surgeon for a second opinion and the surgeon performed an mri and told the patient there's a possible loosening of component that's causing his symptoms.The surgeon recommended revision surgery.The patient lost his job, 6 weeks vacation and insurance.Patient would like to also know why our ct micro scan guidelines weren't used appropriately.The patient stated that per guidelines you need 1-2 weeks prior to surgery and he was only given 2 hrs.The patient is seeking compensation for all his loss and pain.

• Brand Name: MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 4 - 8 MM
• 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): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 11132550
• MDR Text Key: 225564867
• Report Number: 0002249697-2021-00064
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150307
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/28/2022

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 Expiration Date: 11/30/2022
• Device Catalogue Number: 180734-1
• Device Lot Number: 700D70
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 01/07/2021
• Supplement Dates Manufacturer Received: 02/04/2022
• Supplement Dates FDA Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2017
• 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: 54 YR
• Patient Sex: Male
• Patient Weight: 105 KG