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

Model Number 180615

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); Inadequate Osseointegration (2646)

Event Date 12/10/2020

Event Type  Injury  

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.

Event Description

Dr.Revised a right mako medial uni originally done on (b)(6) 2017 due to pain/tibial loosening.He revised to a primary triathlon.He noted the tibia was "easy to get out." update 14/december/2020: spoke to rep, patient was revised from a mako uni knee (with cemented femoral and tibial components) to a triathlon tka.Revision performed robotically.Rep confirmed there are no allegations against the revised femoral component or insert.Rep provided usage reports, x-rays, and explant pictures, and confirmed that no further information will be released by the hospital or surgeon.

Manufacturer Narrative

Reported event: an event regarding loosening involving a mako baseplate was reported.The event was not confirmed.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.Visual inspection of the photographs provided found a tibial baseplate with a large amount of bone cement on the undersize of the base plate , nothing else of noted could be seen.Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated pi which represents a male patient, dob (b)(6) 1968 whose date of implantation is listed as (b)(6) 2017 and explantation (b)(6) 2020.The event description states: ".Revised right mako medial uni.Due to pain/tibial loosening.Revised to primary triathlon." undated x-rays: 2 ap, 1 lat right knee with medial uka in situ with evidence of pf oa and subluxation of medial uka.(b)(6) 2017 implant labels: mako restoris mck: #4 rm/ll femoral, #5 rm/ll tibial baseplate, #5/8 x3 tibial insert.No clinical or pmh, no patient demographics, no op reports, no dated serial x-rays, no examination of explanted components.Based upon the information available for review, neither confirmation of the event description nor preparation of a medical report is possible for this case.Product history review: review of the device history records indicate 105 devices were manufactured and accepted into final stock on (b)(6) 2017 with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.Device not returned.

Event Description

Dr.Revised a right mako medial uni originally done on (b)(6) 2017 due to pain/tibial loosening.He revised to a primary triathlon.He noted the tibia was "easy to get out." update (b)(6) 2020 wg: spoke to rep, patient was revised from a mako uni knee (with cemented femoral and tibial components) to a triathlon tka.Revision performed robotically.Rep confirmed there are no allegations against the revised femoral component or insert.Rep provided usage reports, x-rays, and explant pictures, and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: MCK TIBIAL BASEPLATE-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: 11114410
• MDR Text Key: 225286821
• Report Number: 3005985723-2021-00003
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486000783
• UDI-Public: 00848486000783
• 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
• Type of Report: Initial,Followup
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 180615
• Device Catalogue Number: 180615
• Device Lot Number: 26311116-01
• Date Manufacturer Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 52 YR