MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-LM/RL-SZ 4; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180604

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Rheumatoid Arthritis (1724); Pain (1994)

Event Date 01/04/2017

Event Type  Injury  

Manufacturer Narrative

An event regarding catching and pain involving a mck baseplate was reported.The event was not confirmed.Method & results: device evaluation and results: visual, dimensional, and functional inspection were not performed as the item was not returned.Medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: ¿the persistent symptoms in this lateral unicompartmental knee arthroplasty in a rheumatoid patient with evidence of disease in the medial and patellofemoral compartments is not unexpected.Evidence of lateral subluxation of the tibial component could explain the description of locking and crepitus sensations.There is no examination of the explanted tibial component or operative report of the primary lateral unicompartmental knee arthroplasty available.There is no evidence this clinical situation is related to component design, manufacturing or materials.¿ device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there has been one other events for this lot.Conclusions: the exact cause of the reported pain could not be determined based on the clinician¿s review, ¿the persistent symptoms in this lateral unicompartmental knee arthroplasty in a rheumatoid patient with evidence of disease in the medial and patellofemoral compartments is not unexpected.Evidence of lateral subluxation of the tibial component could explain the description of locking and crepitus sensations.There is no examination of the explanted tibial component or operative report of the primary lateral unicompartmental knee arthroplasty available.There is no evidence this clinical situation is related to component design, manufacturing or materials.¿ no further investigation for this event is possible at this time as no devices and/or insufficient information was received by stryker orthopaedics.If devices and/or additional information become available, this investigation will be reopened.Product surveillance will continue to monitor for trends.Device not available.

Event Description

Patient complains of catching and pain.Update per medical review: ¿the persistent symptoms in this lateral uni-compartmental knee arthroplasty in a rheumatoid patient with evidence of disease in the medial and patella femoral compartments is not unexpected.Evidence of lateral subluxation of the tibial component could explain the description of locking and crepitus sensations.

• Brand Name: MCK TIBIAL BASEPLATE-LM/RL-SZ 4
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: timothy rice ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7005561
• MDR Text Key: 91191084
• Report Number: 0002249697-2017-03217
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2021
• Device Catalogue Number: 180604
• Device Lot Number: 26210616-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2016
• 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
• Patient Age: 51 YR
• Patient Weight: 68