MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MAKO UKR X3 ONLAY INSERT SIZE 5 - 8 MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180735-1-E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 09/15/2023

Event Type  Injury  

Event Description

Revised a left medial tibial insert due to a floating loose body that caused the patient pain.Removed the loose body and put a new tibial insert in.No allegations against the implant made.

Manufacturer Narrative

Reported event: an event regarding revision involving a mako insert was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock on with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to floating loose body that caused the patient pain.The event could not be confirmed as insufficient information was provided.Further information such as device return, pre- and post-operative x-rays, primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text : not available.

Manufacturer Narrative

Please note mfr report # 0002249697-2023-01171 was submitted under the incorrect fda registration number, 0002249697 - jr (howmedica), therefore this record is being closed and new initial mdr will be submitted to the correct fda registration number.

Event Description

Revised a left medial tibial insert due to a floating loose body that caused the patient pain.Removed the loose body and put a new tibial insert in.No allegations against the implant made.

• Brand Name: MAKO UKR X3 ONLAY INSERT SIZE 5 - 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: 17907251
• MDR Text Key: 325340311
• Report Number: 0002249697-2023-01171
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 07613327386028
• UDI-Public: 07613327386028
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180612
• 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: 10/11/2023

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: 180735-1-E
• Device Lot Number: 1P7N3L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2023
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 09/15/2023
• Supplement Dates FDA Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2023
• 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: 69 YR
• Patient Sex: Male