MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 3 - 9 MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Model Number	180733-2
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Poly failed to fit into baseplate so we had to open a new one and the new one went right in.It seems to be just misshaped.
Additional Manufacturer Narrative
An event regarding seating/locking issues involving a mako insert was reported.The event was not confirmed.However, the material analysis report was able to confirm damage.Method & results: device evaluation and results: examination of the device by the material analysis engineer indicated that damage observed on distal surface consistent with contact against a hard object.Medical records received and evaluation: not performed as no medical records were provided.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies complaint history review: there has been no other event for the lot referenced.Conclusions: the event reported for poly failed to fit into baseplate but it is confirmed through visual inspection and material analysis engineer indicated that damage observed on distal surface consistent with contact against a hard object.If the additional information are received, this investigation will be reopened and re-evaluated.No further investigation for this event is required at this time.
Event or Problem Description
Poly failed to fit into baseplate so we had to open a new one and the new one went right in.It seems to be just misshaped.

• Brand Name: MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 3 - 9 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: 6607590
• Report Number: 3005985723-2017-00242
• Device Sequence Number: 739076
• Product Code: NPJ
• UDI-Device Identifier: 00848486016456
• UDI-Public: (01)00848486016456(11)170113(17)220113(10)XA32K6
• Combination Product (Y/N): N
• 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): 09/20/2017

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: 01/13/2022
• Device Model Number: 180733-2
• Device Catalogue Number: 180733-2
• Device Lot Number: XA32K6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2017
• Initial Date Received by Manufacturer: 05/08/2017
• Supplement Date Received by Manufacturer: 08/25/2017
• Initial Report FDA Received Date: 06/02/2017
• Supplement Report FDA Received Date: 09/20/2017
• 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