MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN MAKO RESTORIS ONLAY MEDIAL KNEE; KNEE IMPLANT

Catalog Number UNK_OFL

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348)

Event Date 08/16/2012

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.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

Upon review by joint replacement research for surgeon's milestone payment, patient was noted to be very dissatisfied with their left knee implant and indicated that s/he had since had the implant knee removed, revised, or reoperated on as reported: "nerve pain ((b)(6) 2012)".

• Brand Name: UNKNOWN MAKO RESTORIS ONLAY MEDIAL KNEE
• 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: joann lavatelli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7616581
• MDR Text Key: 111636269
• Report Number: 3005985723-2018-00382
• Device Sequence Number: 1
• Product Code: HRY
• 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: 06/19/2018

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2018
• Initial Date FDA Received: 06/19/2018
• 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): Hospitalization; Required Intervention