MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKO 6 UNI BASEPLATE; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180606

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 06/29/2018

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

As reported: "patient's left medial uni tibial component and poly were revised due to loose cement.A mako 6 uni baseplate part 180606 and 6x9 poly part 180736-2 were explanted.Initial procedure was done at a different facility, no implant records, lots or part numbers available due to not being in the records.No implants returned per hospital policy.Awareness date is (b)(6) 2018.No further information coming".Patient was revised to a tka with navigation.

• Brand Name: MAKO 6 UNI BASEPLATE
• 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: diana avila ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7725209
• MDR Text Key: 115189588
• Report Number: 3005985723-2018-00446
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486000721
• UDI-Public: 00848486000721
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 180606
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2018
• 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: 75 YR