MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-RM/LL-SZ 4; KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P

Catalog Number 180614

Device Problem Osseointegration Problem (3003)

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

Event Date 11/28/2018

Event Type  Injury  

Manufacturer Narrative

If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Event Description

A revision of a tibial component for loosening was reported.

Manufacturer Narrative

An event regarding loosening involving a mako baseplate was reported.The event was not confirmed.Method & results: -product evaluation and results: not performed as product was not returned.-clinician review: no medical records were received for review with a clinical consultant -product history review: indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusion: an event regarding revision due to loosening 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

A revision of a tibial component for loosening was reported.

• Brand Name: MCK TIBIAL BASEPLATE-RM/LL-SZ 4
• Type of Device: KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8197284
• MDR Text Key: 131429031
• Report Number: 3005985723-2018-00783
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486000776
• UDI-Public: 00848486000776
• 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: 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 180614
• Device Lot Number: 2617-0616-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 78