MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-LM/RL-SZ 7; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180607

Device Problem Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 08/01/2017

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Not available.

Event Description

Patient called and stated that he had a bilateral mako plasty on (b)(6) 2012.Patient stated that on or about (b)(6) 2017 he started experiencing pain in his right knee.He went to geisinger and had x-rays and found out that he has a failed tibia.

Manufacturer Narrative

Additional info- ; event executive summary; product code, common device name; catalog #, lot number; date of explant; pma/510(k)#; manufacturing date.An event regarding pain and loosening involving a mako baseplate was reported.The event was confirmed.Method & results: -device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.-medical records received and evaluation: the provided medical records were reviewed by a consulting clinician indicated "review of these records confirms failure of fixation of the tibial component of a medial makoplasty ukr did occur.Abnormal articulation of the femoral/tibial components is seen on x-ray with the femoral component being medially positioned in comparison to the anatomic location of the tibial implant.It is likely the malpositioning of the femoral component lead to abnormal stresses across the articulation causing the tibial component failure." -product 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 reported event was confirmed.However, the exact cause of the event could not be determined based on the review of the medical records by the consulting clinician indicating "review of these records confirms failure of fixation of the tibial component of a medial makoplasty ukr did occur.Abnormal articulation of the femoral/tibial components is seen on x-ray with the femoral component being medially positioned in comparison to the anatomic location of the tibial implant.It is likely the malpositioning of the femoral component lead to abnormal stresses across the articulation causing the tibial component failure." if additional information and/or device becomes available, this investigation will be reopened.

Event Description

Patient called and stated that he had a bilateral mako plasty on (b)(6)2012.Patient stated that on or about (b)(6)2017 he started experiencing pain in his right knee.He went to geisinger and had x-rays and found out that he has a failed tibia.Event update per medical review "an ap x-ray taken on (b)(6)2018 demonstrates lucency beneath the lateral aspect of the tibial component consistent with loosening.The femoral component is medially positioned in comparison to the location of the tibial implant.".

• Brand Name: MCK TIBIAL BASEPLATE-LM/RL-SZ 7
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7403563
• MDR Text Key: 104591372
• Report Number: 0002249697-2018-01030
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 180607
• Device Lot Number: 26230411-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 177