MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN MAKO MEDICAL UKA RESTORIS MCK CASE TYPE: PKA 3.0; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number UNK_OFL

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 02/23/2018

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.

Event Description

It was reported through an investigator initiated study: "dr.Performed initial medial uka surgery on the patient's knee, and followed up with patient post-operatively.Surgery occurred on (b)(6) 2010.The reason for revision was infection and they did not return to dr.To have the revision surgery performed.Provided notes indicate: subject developed rapid infection on (b)(6) 2018, had removal, then on (b)(6) 2018, had revision.Knee was great before that, & cause of infection was unknown.".

• Brand Name: UNKNOWN MAKO MEDICAL UKA RESTORIS MCK CASE TYPE: PKA 3.0
• 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: alessandra chavez ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 10819822
• MDR Text Key: 215903615
• Report Number: 3005985723-2020-00354
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/10/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/15/2020
• Initial Date FDA Received: 11/10/2020
• 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: 80 YR