MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 1-9MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Model Number 180701-2

Device Problems Degraded (1153); Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Injury (2348)

Event Date 08/15/2019

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

This pi is for the right knee.It was reported by surgeon that pre op x-rays showed medial compartment wear.All the standard criteria for medial compartment arthroplasty were fulfilled and surgeon performed a bilateral partial knee medial makoplasty.Primary surgery performed on (b)(6) 2017, by dr the surgeon reported that the cementing technique is as what he would do for all medial mako knees and have had no issues.Patient post op x-rays were good position.Even her post op mri done on her knees 9 months after post surgery showed no loosening and stable implants, nor edema.Post op x-rays showed the implants to be perfectly placed.However in 2019 it was noted that she developed accelerated loosening of both medial implants and this resulted in a bilateral revision total knee arthroplasty.The revision was performed by dr on (b)(6) 2019.The operative notes showed bilateral extensive polyethylene wear with resultant extensive synovitis and loosening.Revision performed using non stryker product.No details provided as patient went to consult another surgeon.Updated: 03 aug 2020 - refer implant picture in intake tab.Recently, the patient came back to visit and informed dr.About the explant implant surgery done in year 2019.The surgeon informed stryker sales rep and would like stryker to investigate the possible causing of the loosening.Update: 6 aug 2020: it was informed by the surgeon that the patient want to file a lawsuit against him.Additional information provided by the surgeon: i find this very peculiar.Photos of the retrieved implants show wear of the plastic that is way too advanced for a 2 year post op surgery.I wouldn¿t expect to see this much wear of the poly for that duration.Especially if the implants were well placed on post op x-rays.

Manufacturer Narrative

Reported event: an event regarding wear involving a mako insert was reported.The event was not confirmed.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs note the following: explanted device shows no remarkable observations.-medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: pis from singapore and relates to the right and left knees of the patient respectively.This is a female patient, dob 11/7/60 described as 146 cm tall and weighing 63 kg.Her date of implantation is listed as 5/21/17 and explantation 8/15/19.The event descriptions are identical with pi - 2457135 for the right and pi - 2452066 for the left knee.The event descriptions state: ".Bilateral medial uka.5/21/17.2019 loosening both medial implants.Bilateral revision tka.Bilateral extensive poly wear.Patient wants to file a lawsuit." 5/22/17 cytopathology report specimen received 5/19/17: "fluid from left knee" "loose bodies of fibrin with chondrogenesis and cartilage." 11/7/16 x-ray ap both knees "erect": mild osteoarthritis both medial compartments with lateral subluxation of both tibia.No clinical or pmh, no operative reports, no examination of explanted components, no post-operative or dated serial x-rays.Based upon the information available for review, neither confirmation of the event descriptions nor preparation of a medical report is possible for this case.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there has been 1 other similar event for the lot referenced.Conclusions: a review of the provided medical information by a clinical consultant indicated: pis from singapore and relates to the right and left knees of the patient respectively.This is a female patient, dob 11/7/60 described as 146 cm tall and weighing 63 kg.Her date of implantation is listed as 5/21/17 and explantation 8/15/19.The event descriptions are identical with pi - 2457135 for the right and pi - 2452066 for the left knee.The event descriptions state: ".Bilateral medial uka.5/21/17.2019 loosening both medial implants.Bilateral revision tka.Bilateral extensive poly wear.Patient wants to file a lawsuit." 5/22/17 cytopathology report specimen received 5/19/17: "fluid from left knee" "loose bodies of fibrin with chondrogenesis and cartilage." 11/7/16 x-ray ap both knees "erect": mild osteoarthritis both medial compartments with lateral subluxation of both tibia.No clinical or pmh, no operative reports, no examination of explanted components, no post-operative or dated serial x-rays.Based upon the information available for review, neither confirmation of the event descriptions nor preparation of a medical report is possible for this case.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary 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.

Event Description

This pi is for the right knee.It was reported by surgeon that pre op x-rays showed medial compartment wear.All the standard criteria for medial compartment arthroplasty were fulfilled and surgeon performed a bilateral partial knee medial makoplasty.Primary surgery performed on (b)(6) 2017, by dr.The surgeon reported that the cementing technique is as what he would do for all medial mako knees and have had no issues.Patient post op x-rays were good position.Even her post op mri done on her knees 9 months after post surgery showed no loosening and stable implants, nor edema.Post op x-rays showed the implants to be perfectly placed.However in 2019 it was noted that she developed accelerated loosening of both medial implants and this resulted in a bilateral revision total knee arthroplasty.The revision was performed by dr on (b)(6) 2019.The operative notes showed bilateral extensive polyethylene wear with resultant extensive synovitis and loosening.Revision performed using non stryker product.No details provided as patient went to consult another surgeon.Updated: (b)(6) 2020 - refer implant picture in intake tab.Recently, the patient came back to visit and informed dr.About the explant implant surgery done in year 2019.The surgeon informed stryker sales rep and would like stryker to investigate the possible causing of the loosening.Update : (b)(6) 2020: it was informed by the surgeon that the patient want to file a lawsuit against him.Additional information provided by the surgeon: i find this very peculiar.Photos of the retrieved implants show wear of the plastic that is way too advanced for a 2 year post op surgery.I would not expect to see this much wear of the poly for that duration.Especially if the implants were well placed on post op x-rays.

• Brand Name: MCK TIBIAL ONLAY INSERT-SZ 1-9MM
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 10454021
• MDR Text Key: 204385347
• Report Number: 3005985723-2020-00275
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486002022
• UDI-Public: 00848486002022
• Combination Product (y/n): N
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: 180701-2
• Device Catalogue Number: 180701-2
• Device Lot Number: 12810315-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 63