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 Material Disintegration (1177); Insufficient Information (3190)

Patient Problems Injury (2348); Ambulation Difficulties (2544); No Clinical Signs, Symptoms or Conditions (4582)

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 left knee.As reported in pi (b)(4): 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 wants 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.

Event Description

This pi is for the left knee.As reported in (b)(4) : 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 wants 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

Updated the weight, expiration and manufacturing dates.Reported event: an event regarding wear involving mako insert was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned clinician review: a review of the provided medical records and/or x-rays by a clinical consultant indicated: from singapore and relates to the right and left knees of the patient respectively.This is a female patient, dob (b)(6) 1960 described as 146 cm tall and weighing 63 kg.Her date of implantation is listed as (b)(6) 2017 and explantation (b)(6) 2019.The event descriptions are identical with the right and the left knee.The event descriptions state: ".Bilateral medial uka.(b)(6) 2017.2019 loosening both medial implants.Bilateral revision tka.Bilateral extensive poly wear.Patient wants to file a lawsuit." on (b)(6) 2017 cytopathology report specimen received 5/2019/2017: "fluid from left knee" "loose bodies of fibrin with chondrogenesis and cartilage." on (b)(6) 2016 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." device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• 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: 10454109
• MDR Text Key: 204387963
• Report Number: 3005985723-2020-00282
• 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: 10/27/2020

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: 07/31/2020
• Device Model Number: 180701-2
• Device Catalogue Number: 180701-2
• Device Lot Number: 12810315-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 63