MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 5-9MM; KNEE IMPLANT

Catalog Number 180705-2

Device Problems Naturally Worn (2988); Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 12/14/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Dr.(b)(6) informed me that he had to explant a (b)(6) old mako pka (medial uni).This was due to an infection that occurred after dental work.He said the implants were not loose malpositioned when he removed them.However there was some premature wear (or so he thought) on the poly.As of the time of removal the patient was doing fine.

Manufacturer Narrative

The following other devices were added to this report after submission of the initial report: mck tibial baseplate-rm/ll-sz 5, cat# 180615, lot# 14140509, mck femoral-rm-ll-sz 5, ofl, cat# 180515, lot# 26140610.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An event regarding infection involving a mck tibial onlay insert-sz 5-9mm was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection of the returned device showed that the device is damaged on the inferior side due to attempt at implantation.Machine markings are still present.There are no signs of delamination or discoloration nor signs of premature wear observed on the device.Medical records received and evaluation: not performed as no medical records were made available.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 and the sterile lot.Conclusions: the source of the infection could not be determined as patient information, clinical history, and results of bloodwork for infection were not provided.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information become available, this investigation will be reopened.

Event Description

Dr.(b)(6) informed me that he had to explant a 4 year old mako pka (medial uni).This was due to an infection that occurred after dental work.He said the implants were not loose malpositioned when he removed them.However there was some premature wear (or so he thought) on the poly.As of the time of removal the patient was doing fine.

• Brand Name: MCK TIBIAL ONLAY INSERT-SZ 5-9MM
• Type of Device: KNEE 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 colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5399572
• MDR Text Key: 37151390
• Report Number: 3005985723-2016-00045
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2016

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: 12/30/2015
• Device Catalogue Number: 180705-2
• Device Lot Number: 12221110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/05/2016
• Initial Date FDA Received: 01/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2010
• 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