MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TIBIAL ONLAY; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number UNK_REC

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

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

Event Date 02/24/2017

Event Type  Injury  

Manufacturer Narrative

The device was not returned to the manufacturer for evaluation.Should additional information become available, a supplemental report will be submitted.

Event Description

Dr.(b)(6) replaced an onlay tibial insert that was originally done on (b)(6) 2017 due to infection.

Manufacturer Narrative

An event regarding infection involving an unknown insert was reported.The event was not confirmed.Method & results: -device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.-medical records received and evaluation: the provided medical information was submitted to a consulting clinician who indicated that: "x-ray printouts, all undated, include two ap¿s of bilateral knee, weightbearing, as well as a lateral of the left and a lateral of the right, and two bilateral patellar views, all demonstrating bilateral cemented mako medial uka components in nominal position with bilateral proximal tibial plates with three proximal screws, and on the right three distal screws, and on the left, four distal screws in the previous fixation, as well as lateral tibial staple in both tibias traversing a healed proximal tibial osteotomy."no patient demographics, no examination of explanted component, no confirmation of ¿infection¿ or bacteriology reports, and no clarification on which side the surgical revision was performed are available.There is no evidence this alleged infection management was related to the uka prosthetic components." -device history review: not performed as the device was not properly identified.-complaint history review: not performed as the device was not properly identified.Conclusions: the event could not be confirmed nor the root cause determined because insufficient information was provided.Provided medical records were submitted to clinician who indicated that no confirmation of ¿infection and there is no evidence this alleged infection management was related to the uka prosthetic components.Further information such as return of device, histopathology report & follow-up notes are needed to investigate this event further.If additional information and/or device becomes available, this investigation will be reopened.

Event Description

Dr.(b)(6) replaced an onlay tibial insert that was originally done on (b)(6) 2017 due to infection.

• Brand Name: UNKNOWN TIBIAL ONLAY
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6435511
• MDR Text Key: 70880861
• Report Number: 3005985723-2017-00142
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/24/2017

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 Catalogue Number: UNK_REC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2017
• Initial Date FDA Received: 03/27/2017
• Supplement Dates Manufacturer Received: 07/27/2017
• Supplement Dates FDA Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 62 YR