MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-RM/LL-SZ 3; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180613

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

Patient Problems Swelling (2091); Injury (2348)

Event Date 08/18/2017

Event Type  Injury  

Manufacturer Narrative

Review of the product history records indicate the products were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not available.

Event Description

According to the physician, femoral component has sunk in and tilted, implant subsided and wear on plastic.Patient had symptoms started this year.Worsened two months ago associated with swelling.Aspirate excluded infection.She was very well before that.Physician had removed mako implant on (b)(6).Revision done using competitor product.Small size 2.5 f 2.5 t ps 12mm insert.

Manufacturer Narrative

An event regarding subsidence involving a mako baseplate was reported.The event reports revision of mako femoral component due to subsidence.Based on the provided information, the product reported in this investigation did not contribute to the event.No alleged deficiencies were reported for this device.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

According to the physician, femoral component has sunk in and tilted, implant subsided and wear on plastic.Patient had symptoms started this year.Worsened two months ago associated with swelling.Aspirate excluded infection.She was very well before that.Physician had removed mako implant on (b)(6).Revision done using competitor product.Small size 2.5 f 2.5 t ps 12mm insert.

• Brand Name: MCK TIBIAL BASEPLATE-RM/LL-SZ 3
• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6915833
• MDR Text Key: 88222366
• Report Number: 3005985723-2017-00475
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2017
• Device Catalogue Number: 180613
• Device Lot Number: 26260512-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2012
• 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