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

Device Problem Osseointegration Problem (3003)

Patient Problem Pain (1994)

Event Date 02/11/2021

Event Type  Injury  

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 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
• Type of Device: 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: joanne mahony ; ida industrial estate; carrigtwohill NA ; EI NA ; 214532800
• MDR Report Key: 11447284
• MDR Text Key: 238704448
• Report Number: 3005985723-2021-00039
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486000707
• UDI-Public: 00848486000707
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 180604
• Device Catalogue Number: 180604
• Device Lot Number: 26041218-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 83