MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 2-9MM; IMPLANT

Catalog Number 180702-2

Device Problem Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 06/24/2015

Event Type  Injury  

Event Description

Dr.(b)(6) performed a uka mako surgery on (b)(6) 2015.He noticed the next day from the x-ray that it appeared the tibial insert was not seated correctly.He decided he would perform a poly exchange on (b)(6).He opened wound, saw the insert was not locked in the posterior.He removed that insert and put another in.He said he thought it looked seated originally but due to the patient's small anatomy he was unable to see the posterior well.He took extra care to make sure the second one was seated correctly and was happy with the outcome.He said the patient was very understanding.

Manufacturer Narrative

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

Manufacturer Narrative

An event regarding alleged seating issues involving a mako insert was reported.The event was not confirmed.Method & results: device evaluation and results: could not be performed as no items associated with the event were returned or made available for identification or evaluation.Medical records received and evaluation: no patient medical records were available for review.Device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: a complaint history review could not be performed as no lot information was provided.Conclusions: the event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

Dr.(b)(6) performed a (b)(4) mako surgery on (b)(6) 2015.He noticed the next day from the x-ray that it appeared the tibial insert was not seated correctly.He decided he would perform a poly exchange on (b)(6).He opened wound, saw the insert was not locked in the posterior.He removed that insert and put another in.He said he thought it looked seated originally but due to the patient's small anatomy he was unable to see the posterior well.He took extra care to make sure the second one was seated correctly and was happy with the outcome.He said the patient was very understanding.

• Brand Name: MCK TIBIAL ONLAY INSERT-SZ 2-9MM
• 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: 4922397
• MDR Text Key: 6016187
• Report Number: 3005985723-2015-00125
• 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: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 180702-2
• Device Lot Number: 12021113-2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/24/2015
• Initial Date FDA Received: 07/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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: 51 YR