MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN_MAKO RESTORIS MCK PF; KNEE IMPLANT

Catalog Number UNK_OFL

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348)

Event Date 02/08/2016

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

This pi is reported on a patient who is part of (b)(6) with isolated pf makoplasty on (b)(6) 2012 which was revised to a tka on (b)(6) 2016 due to pain.No further information was provided from the study site.Complaint 1.

Manufacturer Narrative

Medical records and x-rays were reviewed by a clinician consultant; reported event: an event regarding pain involving a mako implant was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated {.} there is no evidence this narcotic dependent, fibromyalgia patient with a left femoral nerve disorder was in pain due to her patellofemoral arthroplasty components.Findings at revision and serial x-rays did not demonstrate any pathology related to the well-fixed and well-positioned patellofemoral arthroplasty components.{.} device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including lot details and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

This pi is reported on a patient who is part of iis #2015-005 with isolated pf makoplasty on (b)(6) 2012 which was revised to a tka on (b)(6) 2016 due to pain.No further information was provided from the study site.Complaint 1.

• Brand Name: UNKNOWN_MAKO RESTORIS MCK PF
• Type of Device: KNEE IMPLANT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8027809
• MDR Text Key: 125772287
• Report Number: 3005985723-2018-00643
• Device Sequence Number: 1
• Product Code: HSX
• 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: 12/26/2018

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
• Initial Date Manufacturer Received: 10/04/2018
• Initial Date FDA Received: 11/01/2018
• Supplement Dates Manufacturer Received: 11/28/2018
• Supplement Dates FDA Received: 12/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 72