MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK FEMORAL-LM-RL-SZ 3; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Model Number 180503

Device Problem Insufficient Information (3190)

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

Event Date 05/08/2020

Event Type  Injury  

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 Description

Revised femur of uni pka.Case type:pka (mics).

Event Description

Revised femur of uni pka.Case type:pka (mics).

Manufacturer Narrative

Update the manufacturing date and expiration date.Reported event: an event regarding loosening involving a mako femoral component was reported.The event was not confirmed.Method & results: -device evaluation and results: visual, functional, dimensional and material inspection not performed as product was not received.-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.H3 other text : device not returned.

• Brand Name: MCK FEMORAL-LM-RL-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
• MDR Report Key: 10105422
• MDR Text Key: 193082806
• Report Number: 3005985723-2020-00205
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486000554
• UDI-Public: 00848486000554
• Combination Product (y/n): N
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/23/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 180503
• Device Catalogue Number: 180503
• Device Lot Number: 522932-M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/08/2020
• Initial Date FDA Received: 06/01/2020
• Supplement Dates Manufacturer Received: 08/31/2020
• Supplement Dates FDA Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR