MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-LM/RL-SZ 7; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180607

Device Problems Break (1069); Crack (1135); Fracture (1260); Material Integrity Problem (2978)

Patient Problems Bone Fracture(s) (1870); Injury (2348); No Code Available (3191)

Event Date 10/28/2015

Event Type  Injury  

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Event Description

It was noticed on a follow up visit to surgeon on x-ray that the medial uni tibial baseplate is cracked and needs to be revised.Patient's left knee - revised (b)(6) 2015.

Manufacturer Narrative

An event regarding crack/fracture involving a mck tibial baseplate-lm/rl-sz 7 was reported.The event was confirmed.Method and results: device evaluation and results: a material analysis was performed and it concluded that: "the fracture initiated in overload, then progressed through fatigue.Insufficient data was available to determine the cause of the original overload.Eds was performed on the baseplate and was consistent with astm f136 alloy.No materials or manufacturing defects were observed on the surfaces examined." medical records received and evaluation: x-ray images were provided to a consulting clinician for review who indicated the following: the x-ray images dated (b)(6) 2015 show that ¿the components are reduced and appear intact.The lateral x-ray suggests less than optimal cement fixation of the posterior portion of the tibial component." on (b)(6) 2015, the "left lateral x-rays a broken tibial component of the unicondylar is noted with a transverse fracture across the center with subsidence of the posterior fragment into the tibia with a lucency noted under the posterior fragment." the clinician concluded, "in this large male patient, inadequate support to the posterior tibial baseplate resulted in cyclic loading at the junction of the well-fixed anterior baseplate, ultimately ending in fatigue fracture at this level.There is no evidence that manufacturing or material defects contributed to this clinical situation.¿ device history review: there were no reported discrepancies for the referenced lot.Complaint history review: there have been no similar reported events for the provided lot id.Conclusions: the investigation concluded that baseplate fractured in overload.Clinician indicated, "there is no evidence that manufacturing or material defects contributed to this clinical situation." no further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.

Event Description

It was noticed on a follow up visit to surgeon on x-ray that the medial uni tibial baseplate is cracked and needs to be revised.Patient's left knee - revised (b)(6) 2015.

• Brand Name: MCK TIBIAL BASEPLATE-LM/RL-SZ 7
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5235254
• MDR Text Key: 31571944
• Report Number: 3005985723-2015-00266
• Device Sequence Number: 1
• Product Code: NPJ
• 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,Followup
• Report Date: 10/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 180607
• Device Lot Number: 26040314-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 104