MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-RM/LL-SZ 5; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180615

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 06/29/2016

Event Type  Injury  

Manufacturer Narrative

The following other device was also listed in this report: mck femoral-rm-ll-sz 5; cat# 180515; lot# unknown.Mck tibial onlay insert-sz 5-8mm; cat# 180705-1; lot# unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's pain.An evaluation of the device cannot be performed as the device was not returned to the manufacturer due to hospital policy.Additional information has been requested but not made available.Should additional information become available at the later time it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Event Description

The patient underwent revision surgery of mck uni medial due to pain.

• Brand Name: MCK TIBIAL BASEPLATE-RM/LL-SZ 5
• 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: jadwiga degrado ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5823307
• MDR Text Key: 50508065
• Report Number: 3005985723-2016-00231
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/29/2016

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 Catalogue Number: 180615
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2016
• Initial Date FDA Received: 07/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 50 YR
• Patient Weight: 62