MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 4 - 9 MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180734-2

Device Problems Difficult to Insert (1316); Device Difficult to Setup or Prepare (1487)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/19/2018

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate that devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the reported lot.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

As reported: "both tibial inserts would not seat into the baseplate during implantation.Surgeon stated the poly was defective".

Event Description

As reported: "both tibial inserts would not seat into the baseplate during implantation.Surgeon stated the poly was defective".

Manufacturer Narrative

Device not returned.

• Brand Name: MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 4 - 9 MM
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7516321
• MDR Text Key: 108351249
• Report Number: 0002249697-2018-01454
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• PMA/PMN Number: K150307
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 180734-2
• Device Lot Number: 6D8J4X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 05/15/2018
• Supplement Dates Manufacturer Received: 12/23/2020
• Supplement Dates FDA Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR