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

Catalog Number	180735-1
Medical Device Problem Codes	Mechanical Problem (1384); Device Damaged by Another Device (2915); Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reported event: an event regarding alleged "seating/locking issue" involving a triathlon insert was reported.The event was confirmed.Method & results: device evaluation and results: the device was returned in used condition.There were evidence of scratches where contact would have been made with the baseplate while attempting to seat the insert.Examination of the device by the material analysis engineer indicated "damage observed on the inserts consistent with contact against the baseplate." medical records received and evaluation: not performed as no medical records were provided.Device history review: dhr review for the reported lot was satisfactory.Complaint history review: chr review for the reported lot confirmed that there are no other similar events reported.Conclusions: the investigation concluded that based on the returned device, there were evidence of scratches where contact would have been made with the baseplate while attempting to seat the insert.Examination of the device by the material analysis engineer indicated "damage observed on the inserts consistent with contact against the baseplate." no further investigation for this event is required at this time.
Event or Problem Description
The company representative reported that the surgeon had trouble implanting a mako partial knee.This was a primary surgery on the left knee.An update on (b)(6) 2017 reported that the surgeon had trouble getting the implant lined up correctly and couldn't get it to snap down in place.Neither of the inserts were implanted and a third poly was brought in from our office and was implanted.There was a surgical delay of approximately 35-40 minutes while we waited on a third poly to be delivered to the hospital from our office.

• Brand Name: MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 5 - 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: 6652383
• Report Number: 0002249697-2017-01929
• Device Sequence Number: 16431602
• Product Code: NPJ
• UDI-Device Identifier: 00848486016548
• UDI-Public: 00848486016548
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K150307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/19/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/07/2022
• Device Catalogue Number: 180735-1
• Device Lot Number: 6K513T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2017
• Initial Report FDA Received Date: 06/19/2017
• 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: Other