MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK FEMORAL-RM-LL-SZ 5; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180515

Device Problem Malposition of Device (2616)

Patient Problem Pain (1994)

Event Date 08/01/2017

Event Type  Injury  

Manufacturer Narrative

Review of the product history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, 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 (b)(6) 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.".

Event Description

Patient called and stated that he had a bilateral mako plasty on (b)(6) 2012.Patient stated that on or about august, 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.".

Manufacturer Narrative

Corrected lot number.An event regarding malposition involving a mako femoral component was reported.The event was not confirmed.Method & results: product evaluation and results: a material analysis was performed and concluded "the baseplate fractured in fatigue with the crack propagating from the distal to the proximal surface.Delamination, burnishing, scratching and third-body indentation were observed on the insert.These are common damage modes of uhmwpe.Damage was also observed on the insert consistent with the explantation process and contact against the baseplate eds showed that the baseplate was consistent with astm f136 alloy.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined." 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.Material analysis failed to identify any material or manufacturing discrepancies.The root cause of the component loosening and mechanical failure appears to be clinical but cannot be determined definitively as insufficient information was available." 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 not confirmed nor the exact cause of the event could 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.Material analysis failed to identify any material or manufacturing discrepancies.The root cause of the component loosening and mechanical failure appears to be clinical but cannot be determined definitively as insufficient information was available." if additional information becomes available, this investigation will be reopened.

• Brand Name: MCK FEMORAL-RM-LL-SZ 5
• 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: 7610518
• MDR Text Key: 111374645
• Report Number: 3005985723-2018-00371
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486000578
• UDI-Public: 00848486000578
• Combination Product (y/n): N
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: 180515
• Device Lot Number: 26370711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2018
• Date Manufacturer Received: 08/31/2018
• 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