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

Catalog Number	180614
Medical Device Problem Codes	Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Inadequate Osseointegration (2646)
Date of Event	08/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
Mako uni pka performed (b)(6) 2018.Revised to tka for tibial loosening (b)(6) 2018.Revised to triathlon tka.Pain and x-ray changes noted at follow up appointment, revision case booked.
Additional Manufacturer Narrative
An event regarding loosening involving a mako baseplate was reported.The event was confirmed through clinician review of the medical records provided.No product was returned for evaluation, one photograph of the baseplate was provided.The photograph shows the baseplate with the fixation side/underside facing up.There is bone cement, bone ingrowth and blood visible on the baseplate.The explant photograph of the tibial device at revision shows the cemented underside of the baseplate with round-off of the trabecular cement impressions to confirm this device was loose at time of revision.Bone cement remnants in and around the joint space after cementation of a mako partial knee device contributed to third-body wear effects with early osteolysis and consequent tibial loosening requiring revision.Because cementation is part of surgical technique under responsibility of the surgeon, principal failure mode is procedure-related.Indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.An event regarding revision due to loosening was reported.The medical review indicated that: the explant photograph of the tibial device at revision shows the cemented underside of the baseplate with round-off of the trabecular cement impressions to confirm this device was loose at time of revision.Bone cement remnants in and around the joint space after cementation of a mako partial knee device contributed to third-body wear effects with early osteolysis and consequent tibial loosening requiring revision.Because cementation is part of surgical technique under responsibility of the surgeon, principal failure mode is procedure-related.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Mako uni pka performed (b)(6) 2018.Revised to tka for tibial loosening (b)(6) 2018.Revised to triathlon tka.Pain and x-ray changes noted at follow up appointment, revision case booked.

• Brand Name: MCK TIBIAL BASEPLATE-RM/LL-SZ 4
• Common Device Name: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7838785
• Report Number: 3005985723-2018-00520
• Device Sequence Number: 14061813
• Product Code: NPJ
• UDI-Device Identifier: 00848486000776
• UDI-Public: 00848486000776
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K090763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/30/2021
• Device Catalogue Number: 180614
• Device Lot Number: 26040216-01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/07/2018
• Supplement Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 08/31/2018
• Supplement Report FDA Received Date: 10/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 88