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
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/24/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11551855
• Report Number: 0002249697-2021-00505
• Device Sequence Number: 14475222
• Product Code: NPJ
• UDI-Device Identifier: 00848486016647
• UDI-Public: 00848486016647
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K150307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Model Number: 180737-1
• Device Catalogue Number: 180737-1
• Device Lot Number: 608YJ0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR