MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 3 - 8 MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY

Catalog Number	180733-1
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Surgeon attempted to put the poly in and it would not lock.After examining it, the base of it was not flat and therefore wouldn't lock into the base plate.Surgical delay of 5 to 7 minutes.Case type left pka.
Additional Manufacturer Narrative
An event regarding alleged seating/locking issue involving a mako insert was reported.The event was not confirmed.The device was returned in used condition.The scratches and gouges were observed throughout the device.Examination of the device by the material analysis engineer indicated that damage observed consistent with implantation process.-medical records received and evaluation: not performed as no medical records were provided.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies there has been no other event for the lot referenced.The event reported for base of the insert was not flat and therefore wouldn¿t lock into the base plate.The event was not confirmed due to no functional or dimensional inspection conducted since the device found damaged.The returned device showed scratches and gouges throughout the device.Examination of the device by the material analysis engineer indicated that damage observed consistent with implantation process.No further investigation for this event is required at this time.If the additional information are received, this investigation will be reopened and re-evaluated.
Event or Problem Description
Surgeon attempted to put the poly in and it would not lock.After examining it, the base of it was not flat and therefore wouldn¿t lock into the base plate.Surgical delay of 5 to 7 minutes.Case type left pka.

• Brand Name: MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 3 - 8 MM
• Common Device Name: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6865529
• Report Number: 0002249697-2017-02774
• Device Sequence Number: 13833776
• Product Code: NPJ
• UDI-Device Identifier: 00848486016449
• UDI-Public: 00848486016449
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K150307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2017

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: 04/13/2022
• Device Catalogue Number: 180733-1
• Device Lot Number: N302DJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Initial Date Received by Manufacturer: 08/17/2017
• Supplement Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 09/14/2017
• Supplement Report FDA Received Date: 11/28/2017
• 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
• Patient Age: 40 YR