MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN MAKO BICOMPARTMENTAL KNEE REPLACEMENT; KNEE IMPLANT

Catalog Number UNK_OFL

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 12/01/2016

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Mako clinical study complication for an unknown reconstructive product: unexplained pain in a patient with bicompartmental replacement - recent exclusion of infection, but no cause yet found and implants well aligned anatomically, with no adverse features of procedure itself.Second opinion sought and still undergoing investigation.

• Brand Name: UNKNOWN MAKO BICOMPARTMENTAL KNEE REPLACEMENT
• 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: sarah smelko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6527223
• MDR Text Key: 73866886
• Report Number: 3005738134-2017-00006
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2017

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: UNK_OFL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/02/2017
• Initial Date FDA Received: 04/27/2017
• 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): Other