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

Catalog Number 180403

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 02/23/2016

Event Type  Injury  

Manufacturer Narrative

The mck patella resurfacing round dome-26mm; cat# 180320-1; lot# 12490315-1 was also listed in this report.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.

Event Description

Patient was brought back after original surgery for removal of hardware due to infection.Left patella femoral joint removed due to infection.

Manufacturer Narrative

Reported event: an event regarding infection involving a mck patellafemoral sz-3 was reported.The event was not confirmed.Method and results: device evaluation and results: visual, dimensional, and functional inspection were not performed as the item was not returned.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies complaint history review: there have been no other events for this lot.Conclusions: the event could not be confirmed nor the root cause of the reported event determined due to the minimal information received for evaluation.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information becomes available, this investigation will be reopened.

Event Description

Patient was brought back after original surgery for removal of hardware due to infection.Left patella femoral joint removed due to infection.

• Brand Name: MCK PATELLOFEMORAL-L-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: sandra spokane ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5505298
• MDR Text Key: 40522644
• Report Number: 3005985723-2016-00087
• 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: 02/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 180403
• Device Lot Number: 2349791-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2015
• 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: 54 YR
• Patient Weight: 60