MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 7 - 8 MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Model Number 180737-1

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 02/24/2021

Event Type  Injury  

Manufacturer Narrative

The following devices were also listed in this report: mck femoral-rm-ll-sz 7; cat # 180517; lot # 567017-m mck tibial baseplate-rm/ll-sz 7; cat # 180617; lot # 26121118-01 simplex hv us 1 pack; cat # 6194-1-001; lot # 925ab939ea it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event an event regarding infection involving a mako insert was reported.The event was not confirmed.

Event Description

It was reported that a stage 1 revision was performed on the patient's right mako pka due to infection.All components were removed and a spacer was placed.Rep provided the primary imlant sheet and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 7 - 8 MM
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 11551855
• MDR Text Key: 241754676
• Report Number: 0002249697-2021-00505
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486016647
• UDI-Public: 00848486016647
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150307
• 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
• Report Date: 03/23/2021

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 Model Number: 180737-1
• Device Catalogue Number: 180737-1
• Device Lot Number: 608YJ0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2021
• Initial Date FDA Received: 03/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 66 YR