MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK PATELLOFEMORAL-R-SZ 3; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180413

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

Patient Problems Pain (1994); Injury (2348)

Event Date 03/04/2016

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was retained by the hospital and was not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Event Description

Dr.(b)(6) revised a mako pf patient right knee to a primary tka.Dr.(b)(6) said the patient "complained of pain." when the patella button was removed, he noted there was a lot of wear on it.The x-ray supports that the implant was tracking laterally.

Manufacturer Narrative

An event regarding alleged revision due to pain involving a mck patellofemoral-r-sz 3 was reported.The event was not confirmed.Method and results: device evaluation and results: not performed as the device was not returned.Medical records received and evaluation: clinician concluded that, ¿the lateral tracking of the patella can be caused by a number of factors including patient anatomy, muscular imbalance and component malposition.Ongoing maltracking and tilt of the patella would potentially lead to early component wear.It is not known whether the patients pain is related to the patellofemoral issues, the advanced medial knee osteoarthritic changes seen on xray, or both.¿ device history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot indicated.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as operative reports, surgical implant records, pre and post-op x-rays from primary and revision surgeries, outpatient office and clinic notes and the return of the device are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available, this investigation will be reopened.

Event Description

Dr.(b)(6) revised a mako pf patient right knee to a primary tka.Dr.(b)(6) said the patient "complained of pain." when the patella button was removed, he noted there was a lot of wear on it.The x-ray supports that the implant was tracking laterally.

• 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: 5530680
• MDR Text Key: 41304826
• Report Number: 3005985723-2016-00097
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2015
• Device Catalogue Number: 180413
• Device Lot Number: 14020610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2010
• 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: 50 YR