MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-RM/LL-SZ 5; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number	180615
Medical Device Problem Codes	Loss of Osseointegration (2408); Migration (4003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Insufficient Information (4580)
Date of Event	12/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As part of the normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted if additional information becomes available.
Event or Problem Description
Revision of restoris partial knee replacement to total knee replacement.Reason for revision: subsidence of tibial implant.Outcome of revision: size 5 triathlon cr cemented femur, size 6 universal baseplate, 12 x 50mm stem, 6 x 9mm cs insert, 35 asymmetric patella.Note: primary procedure used mako.Revision procedure did not use mako.Primary operation pka 3.0.(b)(6) primary operation.
Event or Problem Description
Revision of restoris partial knee replacement to total knee replacement.Reason for revision: subsidence of tibial implant.Outcome of revision: size 5 triathlon cr cemented femur, size 6 universal baseplate, 12 x 50mm stem, 6 x 9mm cs insert, 35 asymmetric patella.Note: primary procedure used mako.Revision procedure did not use mako.Primary operation pka 3.0.Primary operation.
Additional Manufacturer Narrative
Reported event: an event regarding malposition & loosening involving a mako baseplate was reported.The event was confirmed via medical review.Method & results: product evaluation and results: the reported device was not returned; however, photographs were provided for review.The photographs show a femoral component, tibial baseplate, and insert that have been recently explanted and are covered in blood.There appears to be some cement adhered to the bone-interfacing sides of the devices.Explantation damage is visible on the insert as well as yellow discoloration consistent with absorption of synovial fluid.Clinician review: a review of the provided medical information by a clinical consultant indicated: "conclusion/assessment: no medical records, pre or immediate postoperative x-rays were provided for review.No revision data or x-rays were provided for review.Undated/unlabeled xrays showed loosening of a medial uni tibial component with subsidence and marked anterior slope.Event confirmation: failure of a medial unicompartmental knee arthroplasty can be confirmed.The tibial is loose and has subsided into a marked anterior slope on unlabeled x-rays.A revision cannot be confirmed but would be expected.Root cause: the root cause of the tibial failure cannot be ascertained.The reason for the unconfirmed revision would be tibial loosening and collapse." product history review: review of the device history records indicate 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 lot referenced.Conclusions: it was reported that the patient was revised due to subsidence of the tibial baseplate.A review of the provided medical information by a clinical consultant indicated: "conclusion/assessment: no medical records, pre or immediate postoperative x-rays were provided for review.No revision data or x-rays were provided for review.Undated/unlabeled xrays showed loosening of a medial uni tibial component with subsidence and marked anterior slope.Event confirmation: failure of a medial unicompartmental knee arthroplasty can be confirmed.The tibial is loose and has subsided into a marked anterior slope on unlabeled x-rays.A revision cannot be confirmed but would be expected.Root cause: the root cause of the tibial failure cannot be ascertained.The reason for the unconfirmed revision would be tibial loosening and collapse." 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.

• Brand Name: MCK TIBIAL BASEPLATE-RM/LL-SZ 5
• Common Device Name: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• 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: sanjana talathi ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21111412
• Report Number: 3005985723-2025-00024
• Device Sequence Number: 7679867
• Product Code: NPJ
• UDI-Device Identifier: 00848486000783
• UDI-Public: 00848486000783
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K090763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2025

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: 180615
• Device Lot Number: 26170919-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2020
• 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: 59 YR
• Patient Sex: Male