MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK FEMORAL-LM-RL-SZ 3; KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED

Catalog Number 180503

Device Problem Osseointegration Problem (3003)

Patient Problems Pain (1994); Injury (2348); Inadequate Osseointegration (2646)

Event Date 11/05/2018

Event Type  Injury  

Manufacturer Narrative

An event regarding loosening involving a mako femoral component was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Medical records received and evaluation: not performed as medical records were not provided.Device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusion: an event regarding loosening involving a mako uni femoral component was reported.The exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

It was reported that patient's knee was revised due to loosening after patient complaint of pain.Update: the femoral component was slightly loose.The tibial component and spacer were well-fixed and well-positioned.

• Brand Name: MCK FEMORAL-LM-RL-SZ 3
• Type of Device: KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8126620
• MDR Text Key: 129191849
• Report Number: 3005985723-2018-00701
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486000554
• UDI-Public: 00848486000554
• 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: 12/03/2018

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 Expiration Date: 11/30/2020
• Device Catalogue Number: 180503
• Device Lot Number: 457821-M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2018
• Initial Date FDA Received: 12/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2015
• 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: 54 YR