MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN RESTORIS SZ 4 RIGHT MEDIAL TIBIAL BASEPLATE; KNEE IMPLANT

Catalog Number UNK_OFL

Device Problems Malposition of Device (2616); Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348)

Event Date 10/03/2017

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.

Event Description

Patient had a primary procedure for the medial aspect on (b)(6) 2015.Patient had another procedure for the lateral and pf aspects on (b)(6) 2016 (no stryker devices were explanted at that time).All components except the patella component were explanted on (b)(6) 2017.Revision was performed due to pain.

Manufacturer Narrative

An event regarding revision due to pain involving an unknown mako uni tibial baseplate component was reported.The event was confirmed.Device evaluation and results: could not be performed as the device was not returned.A review of the provided medical records and x-rays by a clinical consultant indicated: osteoarthritis disease progress after medial unicompartmental knee arthroplasty (uka) surgery in 2015 has contributed to a second procedure of lateral and patellofemoral uka in 2016 instead of a preferable conversion to total knee with malalignment after the second uka intervention contributing to overload with clinical symptoms requiring still conversion to a total knee in 2017.A review of the device history records could not be performed as lot code information was not provided.A complaint history review could not be performed as no lot code information was not provided.A review of the provided medical records and x-rays by a clinical consultant indicated that osteoarthritis disease progress after medial unicompartmental knee arthroplasty (uka) surgery in 2015 has contributed to a second procedure of lateral and patellofemoral uka in 2016 in stead of a preferable conversion to total knee with malalignment after the second uka intervention contributing to overload with clinical symptoms requiring still conversion to a total knee in 2017.It is noted that the combination of medial and lateral uka is off-label as per ifu reference.If additional information and/or device becomes available, this investigation will be reopened.

Event Description

Patient had a primary procedure for the medial aspect on (b)(6) 2015.Patient had another procedure for the lateral and pf aspects on (b)(6) 2016 (no stryker devices were explanted at that time).All components except the patella component were explanted on (b)(6) 2017.Revision was performed due to pain.

• Brand Name: UNKNOWN RESTORIS SZ 4 RIGHT MEDIAL TIBIAL BASEPLATE
• Type of Device: KNEE IMPLANT
• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6989775
• MDR Text Key: 90635509
• Report Number: 3005985723-2017-00521
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 72 YR