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 Problem Discomfort (2330)

Event Date 10/31/2016

Event Type  Injury  

Manufacturer Narrative

Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Device not available.

Event Description

Revision of mako (b)(4).

Manufacturer Narrative

An event regarding revision involving a mck patellofemoral-r-sz 3 was reported.The event was not confirmed.Method & results: -device evaluation and results: could not be performed as the subject device was not returned.-medical records received and evaluation: no patient medical records were available for review.-device history review: review of the device history records indicates that all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for this lot.Conclusions: the event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

Revision of mako pfa to tka.

• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6100776
• MDR Text Key: 59835558
• Report Number: 3005985723-2016-00380
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/25/2017

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: 26060510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2016
• Initial Date FDA Received: 11/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/25/2017
• 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): Required Intervention
• Patient Age: 47 YR