MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-LM/RL-SZ 4; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Model Number	180604
Medical Device Problem Codes	Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	05/01/2023
Type of Reportable Event	Serious Injury
Additional 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.H3 other text : device not returned.
Event or Problem Description
Revision from medial uni to total knee replacement.The tibial implant was loose with minimal bonding to the cement mantle.Femur was well fixated.Patient presented with medial knee pain.Left knee.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a mako baseplate was reported.The event was not confirmed.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: the implant record, operative report and x-ray ap x-ray confirm that uni-compartmental medial pka was performed.The x-ray shows the uni-compartmental implants to be in anatomic position with pristine interfaces.The second operative report confirms a conversion of this pka to tka was performed as well.No documentation was provided to explain the root cause for the need of this revision.Should additional information become available i would be happy to further this assessment.-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 loosening of the tibial component.A review of the provided medical records by a clinical consultant indicated "the implant record, operative report and x-ray ap x-ray confirm that uni-compartmental medial pka was performed.The x-ray shows the uni-compartmental implants to be in anatomic position with pristine interfaces.The second operative report confirms a conversion of this pka to tka was performed as well.No documentation was provided to explain the root cause for the need of this revision.Should additional information become available i would be happy to further this assessment." the exact cause of the event could not be determined because insufficient information was provided.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.
Event or Problem Description
Revision from medial uni to total knee replacement.The tibial implant was loose with minimal bonding to the cement mantle.Femur was well fixated.Patient presented with medial knee pain.Left knee.

• Brand Name: MCK TIBIAL BASEPLATE-LM/RL-SZ 4
• 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: alessandra chavez ; 3365 enterprise ave; weston, FL 33331 ; 9546280700
• MDR Report Key: 17000851
• Report Number: 3005985723-2023-00079
• Device Sequence Number: 12405901
• Product Code: NPJ
• UDI-Device Identifier: 00848486000707
• UDI-Public: 00848486000707
• 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: 2019
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2023

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 Expiration Date: 01/09/2024
• Device Model Number: 180604
• Device Catalogue Number: 180604
• Device Lot Number: 26091118-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2019
• 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: Required Intervention; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 87 KG