MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN_RECONSTRUCTIVE_PRODUCT; UNKNOWN - KNEE IMPLANT

Catalog Number UNK_REC

Device Problem Osseointegration Problem (3003)

Patient Problems Injury (2348); Inadequate Osseointegration (2646)

Event Date 05/30/2017

Event Type  Injury  

Manufacturer Narrative

The available information was provided via survey.Additional information has been requested and if received will be provided in a supplemental report.Not available.

Event Description

Survey feedback: mako partial knees fail at a high rate.High rate of loosening.Implants are removed with little to no bone cement on the components.

• Brand Name: UNKNOWN_RECONSTRUCTIVE_PRODUCT
• Type of Device: UNKNOWN - 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6668567
• MDR Text Key: 78442105
• Report Number: 3005985723-2017-00276
• 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
• Type of Report: Initial
• Report Date: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2017
• 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; Required Intervention