MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK FEMORAL- LM-RL- SZ 2; IMPLANT

Catalog Number 180502

Device Problem Unstable (1667)

Patient Problem Damage to Ligament(s) (1952)

Event Date 05/29/2015

Event Type  Injury  

Event Description

(b)(6) revised a right lateral mako pka originally done by dr.(b)(6) on (b)(6) 2013.The reason provided was instability and that the patient had a deficient acl.(b)(6) was going to revise to a tka however he decided to remove the mako implants and put a cement spacer in due to concern over infection.There was possible synovitis.

Manufacturer Narrative

The following other devices were also listed in this report: mck tibial onlay insert- sz 3- 8mm; cat# 180703-1; cat# 12020113-1, mck tibial baseplate- lm/rl- sz 3; cat# 180603; cat# let1522450113.It cannot be determined which, if any of these devices may have caused or contributed to the patient's infection.An evaluation of the device cannot be performed as the device was retained by the hospital and 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

Review of the device history records indicates the lot was manufactured and accepted into final stock on (b)(46 2013.There have been no other events for the lot referenced.The event could not be confirmed nor the root cause of the reported event determined due to the minimal information received.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information becomes available, this investigation will be reopened.

Event Description

(b)(6) revised a right lateral mako pka originally done by dr.(b)(6) on (b)(6) 2013.The reason provided was instability and that the patient had a deficient acl.(b)(6) was going to revise to a tka however he decided to remove the mako implants and put a cement spacer in due to concern over infection.There was possible synovitis.

• Brand Name: MCK FEMORAL- LM-RL- SZ 2
• 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: 4863439
• MDR Text Key: 5812791
• Report Number: 3005985723-2015-00110
• 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: 05/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 180502
• Device Lot Number: 26040113-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2013
• 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