MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-LM/RL-SZ 6; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180606

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 03/12/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Mako partial knee required a revision to a total knee.Update 18/march/2019: spoke to rep.Patient was revised due to tibial collapse.Surgeon reported the patient did not follow medical advice post-operatively and built a barn.The unusual forces involved caused the failure.There are no allegations against any stryker devices or procedures.Rep reported that no further information will be released by the hospital or surgeon.

• Brand Name: MCK TIBIAL BASEPLATE-LM/RL-SZ 6
• 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: collin neitzel ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8493594
• MDR Text Key: 141308244
• Report Number: 3005985723-2019-00286
• 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: 04/08/2019

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
• 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
• Initial Date Manufacturer Received: 03/12/2019
• Initial Date FDA Received: 04/08/2019
• 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: 48 YR