MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 5-8MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180705-1

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 09/21/2016

Event Type  Injury  

Manufacturer Narrative

The following other devices were also listed in this report: mck tibial baseplate-lm/rl-sz 5; cat# 180605; lot# 26040414-02, mck femoral-lm-rl-sz 4; cat# 180504; lot# 228623k-1.It cannot be determined which, if any of these devices may have caused or contributed to the patient's infection.An evaluation of the device cannot be performed as the device was not returned to the manufacturer due to hospital policy.Additional information has been requested.Should additional information become available at the later time it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Event Description

The hospital reported that a periprosthetic infection was detected after a monocompartmental prosthesis (date of implant: (b)(6) 2015).

Manufacturer Narrative

An event regarding infection involving a mck tibial onlay insert-sz 5-8mm 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 for evaluation.-medical records received and evaluation: the provided medical records were reviewed by a consulting clinician who indicated "only x-rays were received but confirmation of infection is needed, need patient demographics, need operative report, clinical and past medical history." -device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.-complaint history review: there has been no other event for the lot referenced and the sterile lot.Conclusions: the source of the infection could not be determined as patient information, clinical history, and results of blood work for infection were not provided.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information and/or devices become available, this investigation will be reopened.

Event Description

The hospital reported that a periprosthetic infection was detected after a monocompartmental prosthesis (date of implant: (b)(6) 2015).

• Brand Name: MCK TIBIAL ONLAY INSERT-SZ 5-8MM
• 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: 6066929
• MDR Text Key: 58765053
• Report Number: 3005985723-2016-00347
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 180705-1
• Device Lot Number: 12211214-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/04/2016
• Initial Date FDA Received: 10/31/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2015
• 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: 67 YR