MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-RM/LL-SZ 5; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Model Number 180615

Device Problem Fracture (1260)

Patient Problems Ambulation Difficulties (2544); Insufficient Information (4580)

Event Date 09/26/2022

Event Type  Injury  

Event Description

Tibial baseplate on restoris mck medial uni has cracked in situ.Original operation date friday (b)(6) 2021.Issue noticed mid-september by surgeon on x-ray and reported to rep.Implant was a size 5 rm/ll onlay tibial baseplate.Plan is to pull out implant and revise to total knee.

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

Tibial baseplate on restoris mck medial uni has cracked in situ.Original operation date (b)(6) 2021.Issue noticed mid-(b)(6) by surgeon on x-ray and reported to rep.Implant was a size 5 rm/ll onlay tibial baseplate.Plan is to pull out implant and revise to total knee.

Manufacturer Narrative

Reported event: an event regarding crack/fracture involving a mako baseplate was reported.The event was confirmed via clinician review.Method & results: product evaluation and results: visual inspection, material analysis, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of medical records with a clinical consultant indicated "review of the lateral view x-ray of the unicondylar arthroplasty demonstrates a vertical fracture of the mid portion of the tibial tray.There is no evidence of component loosening or ostelysis.Material failure of the tibial portion of a unicondylar arthroplasty is confirmed.The root cause of this failure cannot be determined from the limited amount of information provided for review.".Product history review: review of the device history records indicate 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.Conclusions: a review of medical records with a clinical consultant indicated "review of the lateral view x-ray of the unicondylar arthroplasty demonstrates a vertical fracture of the mid portion of the tibial tray.There is no evidence of component loosening or ostelysis.Material failure of the tibial portion of a unicondylar arthroplasty is confirmed.The root cause of this failure cannot be determined from the limited amount of information provided for review." no further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.Product surveillance will continue to monitor for trends.

• Brand Name: MCK TIBIAL BASEPLATE-RM/LL-SZ 5
• 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: perla zima ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 15632145
• MDR Text Key: 302004294
• Report Number: 3005985723-2022-00133
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 180615
• Device Catalogue Number: 180615
• Device Lot Number: 26170919-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/13/2019
• 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; Other; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 140 KG