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 Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/11/2021
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.Device not returned.
Event or Problem Description
Patient had a revision.Patient had a left mako partial knee (restoris) insitu approximately 12 months old.They presented with medial pain, mri showed medial tibial loosening.Intra op tibial baseplate lifted off with no sign of cement interdigitation.Primary triathlon knee implanted.

• 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.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 11447284
• Report Number: 3005985723-2021-00039
• Device Sequence Number: 14357187
• 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 Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/09/2021

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: 180604
• Device Catalogue Number: 180604
• Device Lot Number: 26041218-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 03/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 83