MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-RM/LL-SZ 6; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Model Number 180616

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 02/06/2020

Event Type  Injury  

Manufacturer Narrative

An event regarding pain involving a mako baseplate was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: cannot confirm event, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from 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 primary operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components 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.

Event Description

This pi is for the implants used in patient 2 of 3.(b)(6) yo female, surgery (b)(6) 2019.As reported by surgeon: attached are xrays of three patients i previously discussed.All have concerning radiolucencies underneath the tibial baseplate that appeared several months post op.Thus far, none have required revision but all have some degree of pain (mostly medial).Again i never saw this prior the mics transition.Let me know your thoughts and if any other surgeons have seen this issue.More recently, i have been using a 2mm drill to perforate the sclerotic tibial surface to promote better cement interdigitation and my results seem to be much better.Case type: pka 3.0.

Manufacturer Narrative

Reported event: an event regarding pain involving a mako baseplate was reported.The event was not confirmed.Method & results product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted.Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: cannot confirm event, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from 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 primary operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components 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.Product surveillance will continue to monitor for trends.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product nonconformity or unanticipated hazard.H3 other text : device not returned.

Event Description

This pi is for the implants used in patient 2 of 3.69 yo female, surgery on (b)(6) 2019.As reported by surgeon: attached are xrays of three patients i previously discussed.All have concerning radiolucencies underneath the tibial baseplate that appeared several months post op.Thus far, none have required revision but all have some degree of pain (mostly medial).Again i never saw this prior the mics transition.Let me know your thoughts and if any other surgeons have seen this issue.More recently, i have been using a 2mm drill to perforate the sclerotic tibial surface to promote better cement interdigitation and my results seem to be much better.Case type: pka 3.0.

• Brand Name: MCK TIBIAL BASEPLATE-RM/LL-SZ 6
• 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: 9794038
• MDR Text Key: 182780481
• Report Number: 3005985723-2020-00141
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486000790
• UDI-Public: 00848486000790
• 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: 04/06/2020

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
• Device Operator: Health Professional
• Device Model Number: 180616
• Device Catalogue Number: 180616
• Device Lot Number: 26100416-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 03/05/2020
• Supplement Dates Manufacturer Received: 03/11/2020
• Supplement Dates FDA Received: 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR