MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK PATELLOFEMORAL-R-SZ 3; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180413

Device Problem Insufficient Information (3190)

Patient Problems Arthritis (1723); Pain (1994); Injury (2348)

Event Date 09/16/2019

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.The following devices were also listed in this report: mck patella resurfacing round dome-32 mm; cat# 180320-3; lot# 12151114-2.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

Revision of previous right mako pf replacement due to pain and progression of osteoarthritis.Initial surgery (b)(6) 2017.Revised with primary tkr.

• Brand Name: MCK PATELLOFEMORAL-R-SZ 3
• 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: collin neitzel ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 9185157
• MDR Text Key: 162449837
• Report Number: 3005985723-2019-00730
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486000486
• UDI-Public: 00848486000486
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 10/14/2019

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: 180413
• Device Lot Number: 2405201-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2019
• Initial Date FDA Received: 10/14/2019
• 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
• Patient Weight: 66