MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 4-10MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Model Number 180704-3

Device Problem Unstable (1667)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 06/11/2020

Event Type  Injury  

Manufacturer Narrative

Initial report submitted under mfr# 0002249697-2021-01288.Upon additional information received, it was confirmed the device belongs to a different registration number.The following devices were also listed in this report: mck femoral-lm-rl-sz 2; cat # 180502; lot # 545795-m.Mck tibial baseplate-lm/rl-sz 4; cat # 180604; lot # ms00060319.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: an event regarding rom involving a mako insert 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 remains implanted.Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: materials reviewed: 06/11/2020: stryker pi report.(b)(6) 2020: intraoperative record.Left tka.Pain cocktail and vanco powder.Cemented with palacos r.Restoris mck onlay uni 4 x10mm poly, #2 lm/rl femoral, #4 tibial baseplate.(b)(6) 2020: operative note.Left uni medial knee.Mako.(b)(6) yo woman.Recut due to balance issues.Too tight, downsized femur to a #2.No complications.(b)(6) 2020: h and p.Ongoing pain in knee.Stable medical history.Stable ligaments, mild decrease in strength.Motion 0-1000.X-rays bone on bone in varus.Failed conservative rx.Kss 50 pain and function.Confirmation: the event cannot be confirmed as there is no documentation of the manipulation event.Root cause: a root cause cannot be confirmed as there is no documentation of the reported event.Product history review: 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 reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device 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

Information received from study site indicates "knee manipulation under anesthesia.".

Manufacturer Narrative

Reported event an event regarding rom involving a mako insert 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 remains implanted.Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: materials reviewed: 06/11/2020: stryker pi report.06/11/2020: intraoperative record.Left tka.Pain cocktail and vanco powder.Cemented with palacos r.Restoris mck onlay uni 4 x10mm poly, #2 lm/rl femoral, #4 tibial baseplate.06/11/2020: operative note.Left uni medial knee.Mako.62 yo woman.Recut due to balance issues.Too tight, downsized femur to a #2.No complications.06/11/2020: h and p.Ongoing pain in knee.Stable medical history.Stable ligaments, mild decrease in strength.Motion 0-1000.X-rays bone on bone in varus.Failed conservative rx.Kss 50 pain and function.Confirmation: the event cannot be confirmed as there is no documentation of the manipulation event.Root cause: a root cause cannot be confirmed as there is no documentation of the reported event.-product history review: 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 reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device 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

Information received from study site indicates "knee manipulation under anesthesia.".

• Brand Name: MCK TIBIAL ONLAY INSERT-SZ 4-10MM
• 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: 12590477
• MDR Text Key: 275466216
• Report Number: 3005985723-2021-00167
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486000905
• UDI-Public: 00848486000905
• Combination Product (y/n): N
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2021
• Device Model Number: 180704-3
• Device Catalogue Number: 180704-3
• Device Lot Number: 12180516-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR