MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK FEMORAL-RM-LL-SZ 2; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Model Number	180512
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	07/07/2020
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
Dr.Revised a right mako medial uni originally done on (b)(6) 2014 to a primary triathlon cementless total knee.The reason was for pain.Dr.Noted the femoral implant was loose.Update 08/july/2020 wg: rep provided the primary operative report, pre-revision x-rays, and revision usage sheet and reported that no further information will be released.

• Brand Name: MCK FEMORAL-RM-LL-SZ 2
• 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: 10359648
• Report Number: 3005985723-2020-00244
• Device Sequence Number: 972248
• Product Code: NPJ
• UDI-Device Identifier: 00848486000615
• UDI-Public: 00848486000615
• 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: 2014
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/03/2020

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: 180512
• Device Catalogue Number: 180512
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 08/03/2020
• 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