MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 3-9MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Model Number	180703-2
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/06/2020
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
The doctor revised a mako mck medial pkr due to aseptic loosening of the femoral component.He thinks it was due to cement technique at time of implantation.The construct is two years old.There is visible wear on the poly insert.He believes it is too young to have experienced poly wear, and would like the insert to be examined, assessed and reported back to him please.

• Brand Name: MCK TIBIAL ONLAY INSERT-SZ 3-9MM
• 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: 10477464
• Report Number: 3005985723-2020-00293
• Device Sequence Number: 16879677
• Product Code: NPJ
• UDI-Device Identifier: 00848486000868
• UDI-Public: 00848486000868
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K090763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/01/2020

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: 180703-2
• Device Catalogue Number: 180703-2
• Device Lot Number: 12251116-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 09/01/2020
• 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: 70 YR
• Patient Weight: 91