MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 3-9MM; KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P

Catalog Number 180703-2

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 07/22/2016

Event Type  Injury  

Manufacturer Narrative

This event was reported through an attorney, as a result of a legal claim.Due to the ongoing litigation no additional information is available at this time.If additional information is received it will be reported on a supplemental report.Device not returned to the manufacturer.

Event Description

By way of a letter communication dated july 14, 2016 and received on july 21st, it is alleged that patient had a primary knee replacement surgery at an unknown date and was revised on (b)(6) 2016.

Event Description

By way of a letter communication dated (b)(6) 2016 and received on july 21st, it is alleged that patient had a primary knee replacement surgery at an unknown date and was revised on june 28,2016.Update: partial unicompartmental knee replacement of right knee using makoplasty.

Manufacturer Narrative

Additional devices listed in this event: catalog: 180613 description: mck tibial baseplate-rm/ll-sz 3 restoris mck lot: 32052915-5 catalog: 180512 description: mck femoral-rm-ll-sz 2 restoris mck lot: 2079521-1 at this time, it cannot be determined which, if any of the reported devices may have caused or contributed to the patient's experience.Therefore, the event will be reported with one product and the remaining devices will be referenced in section h10 of the supplemental med watch report.An event regarding revision involving a mako insert was reported.The event was not confirmed.Method & results: -product evaluation and results: visual, dimensional, functional inspection, and material analysis were not performed as the item was not returned.-clinician review: rejected for medical review by dr.Jaffe today - no confirmation of event, need revision operative report, x-rays, patient demographics, clinical history and examination of explanted components.-product history review: a review of the product history records could not be performed as the lot code was not identified.-complaint history review: a complaint history review could not be performed as lot code was not identified.Conclusions: the reported event for revision could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided.Further information such as medical documentation and returned devices are needed.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

• Brand Name: MCK TIBIAL ONLAY INSERT-SZ 3-9MM
• Type of Device: KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 5890962
• MDR Text Key: 52611186
• Report Number: 0002249697-2016-02667
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 180703-2
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR