MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-LM/RL-SZ 6; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Model Number	180606
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	12/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "revised a mako left medial uni due to tibial loosening and disease progression".Patient was revised to a tka.
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 if additional information becomes available.Device not returned.

• Brand Name: MCK TIBIAL BASEPLATE-LM/RL-SZ 6
• Common Device Name: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 16193445
• Report Number: 3005985723-2023-00008
• Device Sequence Number: 11805537
• Product Code: NPJ
• UDI-Device Identifier: 00848486000721
• UDI-Public: 00848486000721
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K090763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/18/2023

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 Model Number: 180606
• Device Catalogue Number: 180606
• Device Lot Number: 26570917-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2022
• Initial Report FDA Received Date: 01/18/2023
• 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: Required Intervention; Hospitalization
• Patient Age: 88 YR
• Patient Sex: Male