MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 5-9MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Model Number 180705-2

Device Problem Naturally Worn (2988)

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

Event Date 06/30/2020

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

Restoris implants were revised due to femoral and tibial implant loosening.Original surgery was performed on (b)(6) 2017 at (b)(6) private hospital (b)(6).Revision was done on (b)(6) 2020 at the same hospital and by the same surgeon.New implants of the same type were implanted.Femoral and tibial component of the same size were used, the insert thickness was changed from 9 mm to 12 mm.The revision was carried out successfully.

Event Description

Restoris implants were revised due to femoral and tibial implant loosening.Original surgery was performed on (b)(6) 2017 at (b)(6) hospital (b)(6).Revision was done on (b)(6) 2020 at the same hospital and by the same surgeon.New implants of the same type were implanted.Femoral and tibial component of the same size were used, the insert thickness was changed from 9 mm to 12 mm.The revision was carried out successfully.

Manufacturer Narrative

Reported event: an event regarding revision involving a mako insert was reported.The event was not confirmed.Method & results: device evaluation and results: the device was not returned.Visual inspection of the received image of the device noted nothing noteworthy on the device.Dimensional, functional and material analysis could not be performed as the device was not returned.Medical records received and evaluation: no medical records were received for review with a clinical consultant device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusion: the event could not be confirmed nor the exact cause of the event be determined because insufficient information was provided.Additional information including device details, 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.

• Brand Name: MCK TIBIAL ONLAY INSERT-SZ 5-9MM
• 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: 10298341
• MDR Text Key: 199683972
• Report Number: 3005985723-2020-00237
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486000929
• UDI-Public: 00848486000929
• 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: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 180705-2
• Device Catalogue Number: 180705-2
• Device Lot Number: 00848486000929
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR