MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 5-9MM; KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P

Catalog Number 180705-2

Device Problems Unstable (1667); Dent in Material (2526); Scratched Material (3020); Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 07/03/2018

Event Type  Injury  

Manufacturer Narrative

A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available, the evaluation summary will be submitted in a supplemental report.

Event Description

Patient admitted for poly exchange, plan to increase poly thickness due to joint looseness.

Event Description

Patient admitted for poly exchange, plan to increase poly thickness due to joint looseness.

Manufacturer Narrative

Correction: expiration date.An event regarding revision due to instability involving a mako insert was reported.The event was confirmed through clinician review of the medical records provided.Method & results: -device evaluation and results: the material analysis report(mar) concluded: burnishing, scratching and third-body indentations were observed on the insert.These are common damage modes of uhmwpe.Backside impression markings were observed on the distal surface of the insert, consistent with contact against the baseplate.Damage consistent with the explantation process was also observed on the insert.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-clinician review: a review of the provided medical records revealed "suboptimal bearing thickness after mako medial unicondylar arthroplasty contributed to early instability requiring revision surgery to increase bearing height within 1-year of primary surgery.Obesity (bmi=38) a minor secondary factor to increase general joint load levels.-product history review: indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusion: the event regarding revision due to instability involving a mako insert was confirmed.The mar concluded: burnishing, scratching and third-body indentations were observed on the insert.These are common damage modes of uhmwpe.Backside impression markings were observed on the distal surface of the insert, consistent with contact against the baseplate.Damage consistent with the explantation process was also observed on the insert.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Review of the medical records provided revealed suboptimal bearing thickness after mako medial unicondylar arthroplasty contributed to early instability requiring revision surgery to increase bearing height within 1-year of primary surgery.Obesity (bmi=38) a minor secondary factor to increase general joint load levels.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: MCK TIBIAL ONLAY INSERT-SZ 5-9MM
• Type of Device: KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7732537
• MDR Text Key: 115468039
• Report Number: 3005985723-2018-00447
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486000929
• UDI-Public: 00848486000929
• Combination Product (y/n): N
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 180705-2
• Device Lot Number: 12020716-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Date Manufacturer Received: 09/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 122