MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MCK PATELLOFEMORAL-R-SZ 4; KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P

Catalog Number 180414

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pain (1994); Injury (2348)

Event Date 08/24/2015

Event Type  Injury  

Manufacturer Narrative

The following other device was also listed in this report: mck patella resurfacing round dome-35mm; cat# 180320-4; lot# 12150710.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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 originally done on (b)(6) 2012 to a triathlon primary tka due to pain and disease progression.

Manufacturer Narrative

An event regarding pain and disease progression involving a mako patellofemoral component was reported.The event was not confirmed.Method & results: -device evaluation and results: could not be performed as no items associated with the event were returned or made available for identification or evaluation.-medical records received and evaluation: review of medical records was not performed as no medical records were received for review with a clinical consultant.-device history review: review of the device history records indicates the devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: based on the device identification the complaint databases and there were no similar reported events for this lot.Conclusions: the exact cause of the reported pain could not be determined.A capa trend analysis was conducted for the reported failure mode and concluded pain may result from other factors not necessarily related to the device.No further investigation for this event is possible at this time as no devices and/or insufficient information was received by stryker orthopaedics.If devices and/or additional information become available, this investigation will be reopened.

Event Description

Dr.(b)(6).Revised a mako pf originally done on (b)(6) 2012 to a triathlon primary tka due to pain and disease progression.

• Brand Name: MCK PATELLOFEMORAL-R-SZ 4
• Type of Device: KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5087095
• MDR Text Key: 26152774
• Report Number: 3005985723-2015-00163
• 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: Followup
• Report Date: 08/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: 180414
• Device Lot Number: 14900709-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2011
• 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: 61 YR