MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL INLAY POLY-SZ 6-6.5MM; KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P

Catalog Number	180726-1
Medical Device Problem Codes	Degraded (1153); Unintended Movement (3026)
Health Effect - Clinical Code	Arthritis (1723)
Date of Event	10/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through stryker facebook page: "my mako knee lasted 8 weeks ! i had a revision a few years later!".04-dec-2023: update per conversation with patient: "patient had a primary right mako partial knee and was revised to convert to a full knee.Patient reported that surgeon chose to convert to a full knee as the "outer portion of the his native knee became bone on bone".Update: per clinician review of provided medical records: x-rays in 2016 and 2017 showed advanced oa of the lateral compartment and wear of the polyethylene with some likely subsidence.
Additional Manufacturer Narrative
An event regarding wear and subsidence involving a mako insert was reported.The event was confirmed via clinician review of the provided medical records.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: a review of the provided medical records by a clinical consultant indicated: "conclusion/assessment: patient underwent a mako by report on 10/01/2014.X-rays in 2016 and 2017 showed advanced oa of the lateral compartment and wear of the polyethylene with some likely subsidence.No preoperative history or records, initial postoperative radiographs or records, or postoperative history were provided for review.The pi report indicates a revision was performed but records were not provided for this procedure.Event confirmation: a uni knee procedure can be confirmed.A revision surgery cannot be confirmed.Root cause: the root cause of the primary procedure cannot be determined.The root cause of the revision was likely advancing oa in the lateral compartment, there was polyethylene wear as well" -product history review: the stryker and millstone medical databases were reviewed and no dhr could be found for this lot code.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to the outer portion of the the patient's native knee became bone on bone.A review of the provided medical records by a clinical consultant indicated: "conclusion/assessment: patient underwent a mako by report on 10/01/2014.X-rays in 2016 and 2017 showed advanced oa of the lateral compartment and wear of the polyethylene with some likely subsidence.No preoperative history or records, initial postoperative radiographs or records, or postoperative history were provided for review.The pi report indicates a revision was performed but records were not provided for this procedure.Event confirmation: a uni knee procedure can be confirmed.A revision surgery cannot be confirmed.Root cause: the root cause of the primary procedure cannot be determined.The root cause of the revision was likely advancing oa in the lateral compartment, there was polyethylene wear as well" further information such as return of the device, pathology reports, additional pre- and post-operative x-rays, and the revision 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.The following device was also listed in this report: cat# 180516; mck femoral-rm-ll-sz 6; lot# 26110613-01.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

• Brand Name: MCK TIBIAL INLAY POLY-SZ 6-6.5MM
• Common Device Name: KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18510303
• Report Number: 3005985723-2024-00005
• Device Sequence Number: 17939242
• Product Code: NPJ
• UDI-Device Identifier: 00848486001155
• UDI-Public: 00848486001155
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K082172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/15/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 180726-1
• Device Lot Number: 12221009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 01/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 88 KG