MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN RIGHT PFA; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number UNK_JR

Device Problem Insufficient Information (3190)

Patient Problems Scar Tissue (2060); Injury (2348)

Event Date 08/30/2017

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.

Event Description

This pi is for the scar tissue debridement on (b)(6) 2017.The following were reported as failures and included in a report received as proof of milestone on an iis: 2015-021.The study coordinator does not recall reporting these previously and the information included here is limited to what was in the report: dos: (b)(6) 2016, right pfa; 1.On (b)(6) 2017-bakers cyst excision 2.On (b)(6) 2017 knee scope-pfa "excellent"; scar tissue debridement.

Manufacturer Narrative

Upon additional information received, it was discovered that the device reported in this event belongs to a different registration.A new mdr has been filled under mfr# 3005985723-2021-00021.Investigation results and conclusions will continue using the aforementioned mfr.

Event Description

This pi is for the scar tissue debridement on (b)(6) 2017.The following were reported as failures and included in a report received as proof of milestone on an iis: (b)(4).The study coordinator does not recall reporting these previously and the information included here is limited to what was in the report: dos: (b)(6) 2016, right pfa; 1.On (b)(6) 2017-bakers cyst excision 2.On (b)(6) 2017 knee scope-pfa "excellent"; scar tissue debridement.

• Brand Name: UNKNOWN RIGHT PFA
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9512742
• MDR Text Key: 184887538
• Report Number: 0002249697-2019-04085
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 33 YR