MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN_MAKO_PRODUCT; IMPLANT

Catalog Number UNK_MAKO

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Date 09/14/2015

Event Type  Injury  

Manufacturer Narrative

Device description reported as an unknown patella insert.An evaluation of the device cannot be performed as the device was not returned to the manufacturer due to hospital policy.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Event Description

It was reported that patient had a left patella revision.Patient fell 2 weeks prior while playing street hockey.The patella button sheared off the patella as a result of the fall and surgeon removed the patella and cemented in a new patella.All other components were well fixed and remained implanted.

• Brand Name: UNKNOWN_MAKO_PRODUCT
• 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: jadwiga degrado ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5145539
• MDR Text Key: 28074480
• Report Number: 3005985723-2015-00189
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Report Date: 09/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_MAKO
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2015
• 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: 61 YR