MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-RM/LL-SZ 3; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Model Number	180613
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	10/29/2020
Type of Reportable Event	Serious Injury
Additional 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.Device not returned.
Event or Problem Description
A restoris baseplate was revised due to loosening.Right medial unicomp.
Additional 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 device was not returned.Visual inspection of the received image of the device noted the explant covered with biological material in the posterior part.Dimensional, functional inspection, and material analysis were not performed as the item was not returned.Clinician review: no medical records were received for review with a clinical consultant.Device 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: it was reported that the patient was revised due loose baseplate.The event could not be confirmed, nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided.Further information such as medical documentation and returned devices are needed.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.Device not returned.
Event or Problem Description
A restoris baseplate was revised due to loosening.Right medial unicomp.

• Brand Name: MCK TIBIAL BASEPLATE-RM/LL-SZ 3
• 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: 10874768
• Report Number: 3005985723-2020-00367
• Device Sequence Number: 19654659
• Product Code: NPJ
• UDI-Device Identifier: 00848486000769
• UDI-Public: 00848486000769
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K090763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2021

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 Model Number: 180613
• Device Catalogue Number: 180613
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 01/04/2021
• 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: 60 YR
• Patient Weight: 71