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

Device Problems Fitting Problem (2183); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/08/2017

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event 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.

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 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
• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6607590
• MDR Text Key: 76725125
• Report Number: 3005985723-2017-00242
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486016456
• UDI-Public: (01)00848486016456(11)170113(17)220113(10)XA32K6
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150307
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2017
• 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): Other