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 Problem Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2014

Event Type  malfunction  

Manufacturer Narrative

Final report submitted based on the results of investigation conclusion.This device was packed used the previous packaging (clam shell pack).This pack utilize two mylar/tyvek pouches one inner and one outer.The package had both component seals broken large enough to fit the device through.Actual packaging is not using this components but there is product on the field that could potentially have this condition.Millstone was contacted to provide inspection evidence of the parts being within specifications when received.Validation of packaging was performed pq 2008-101 metal 5yr aging.

Event Description

During a primary knee procedure, the sterile inner packaging was found to be torn thereby questioning the sterility of the implant and was not used in surgery.Another implant of same size was readily available and was used to complete the surgery without delay or any adverse consequence.

• 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: jonathan reeves ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 5605681
• MDR Text Key: 43554899
• Report Number: 3005985723-2016-00130
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Catalogue Number: 180607
• Device Lot Number: 26110810
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 3005985723-12-28-15-004R
• Patient Sequence Number: 1
• Patient Outcome(s): Other