MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MCK TIBIAL ONLAY INSERT-SZ 3-10MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY

Catalog Number 180703-3

Device Problems Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Discomfort (2330)

Event Date 02/17/2012

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.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to manufacturer.

Event Description

Dx tibial loosening, l uka, possible occult infection.Positive bone scan, slight elevation of white cell count in joint aspirate.Revision of left tka.

Manufacturer Narrative

An event regarding tibial loosening and possible infection involving a mako insert was reported.There is no indication that the product reported in this investigation contributed to the event and there is no alleged issue with the mako insert.No further investigation is required at this time.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

Dx tibial loosening, l uka, possible occult infection.Positive bone scan, slight elevation of white cell count in joint aspirate.Revision of left tka.

• Brand Name: MCK TIBIAL ONLAY INSERT-SZ 3-10MM
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY
• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6437343
• MDR Text Key: 70972504
• Report Number: 3005985723-2017-00146
• 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: study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/22/2017

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: 03/01/2016
• Device Catalogue Number: 180703-3
• Device Lot Number: 12120209-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/27/2017
• Initial Date FDA Received: 03/27/2017
• Supplement Dates Manufacturer Received: 10/27/2017
• Supplement Dates FDA Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2011
• 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): Other; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 90