MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-RM/LL-SZ 3; IMPLANT

Catalog Number 180613

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978); Insufficient Information (3190)

Patient Problems Cyst(s) (1800); Bone Fracture(s) (1870); Injury (2348)

Event Date 06/22/2015

Event Type  Injury  

Event Description

Patient had a right pkr makoplasty done on monday (b)(6).She was in her second phase of post op same day rehab therapy and she heard a crunch.Doctor had an x-ray taken and she had a medial proximal tibial fracture.He repaired the fracture with a plate and screws.After reviewing pre op ct scan there appeared to be a posterior area that appeared to have a depression or cyst.It was not noticed or recognized pre operatively.

Manufacturer Narrative

An evaluation of the device cannot be performed as the device remained implanted in the patient and was not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Manufacturer Narrative

An event regarding alleged periprosthetic fracture involving a mako baseplate was reported.The event was confirmed.Conclusion: method & results: device evaluation and results: visual, dimensional and functional analysis could not be performed as the device was not returned.Medical records received and evaluation: a review of the provided medical records and/or x-rays by a clinical consultant indicated it is possible the tibial preparation created an unrecognized defect in the tibial cortex which progressed to a displaced fracture.There is no indication that faulty design, manufacturing or materials of the implants were responsible for the early periprosthetic fracture in this case.Device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the reported lot.Conclusions: clinician review of the provided information determined that it is possible the tibial preparation created an unrecognized defect in the tibial cortex which progressed to a displaced fracture.There is no indication that faulty design, manufacturing or materials of the implants were responsible for the early periprosthetic fracture in this case.If additional information becomes available, this investigation will be reopened.

Event Description

Patient had a right pkr makoplasty done on (b)(6).She was in her second phase of post op same day rehab therapy and she heard a crunch.Dr had an x-ray taken and she had a medial proximal tibial fracture.He repaired the fracture with a plate and screws.After reviewing pre op ct scan there appeared to be a posterior area that appeared to have a depression or cyst.It was not noticed or recognized pre operatively.

• Brand Name: MCK TIBIAL BASEPLATE-RM/LL-SZ 3
• Type of Device: IMPLANT
• 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 navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4919094
• MDR Text Key: 6027668
• Report Number: 3005985723-2015-00124
• 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: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2015
• Device Catalogue Number: 180613
• Device Lot Number: 26340115-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2015
• 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: 69 YR
• Patient Weight: 77