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

Model Number	180605
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	06/21/2023
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.
Event or Problem Description
It was reported that the patient's knee was converted from an mck pka to a competitor tka.Mps reported original suspicion was tibial subsidence.Mps was not present for the revision, but after the case was provided with the explants and the baseplate was broken in half.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a mako baseplate was reported.The event was confirmed.Method & results: -device evaluation and results: visual inspection and material analysis: material evaluation was completed and indicated the following comments: figure shows a stereo microscope image of the full fracture surface associated with the posterior side of the baseplate.Figures show higher magnification stereo microscope images of the fracture surfaces associated with the posterior and anterior sides of the baseplate, respectively.Based on macroscopic surface features observed, including river lines, the approximate origin location (o) was determined.The fracture origin was observed at or near the laser marking on the baseplate, approximately where the letter ¿z¿ of the size indicator was laser marked.Review of tibial baseplate, catalogue # 180605, lot code 26050221 confirmed fracture of the baseplate.Characterisation using stereo microscopy and scanning electron microscopy confirmed fracture through the baseplate.The device fractured in fatigue and the fracture initiated at or near the location of laser marking on the baseplate.-clinician review: no medical records were received for review with a clinical consultant.-device history review: review of the device history records indicate 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 lot referenced.Conclusion: it was reported that patient was revised due to fractured baseplate visual inspection and material analysis indicated: figure shows a stereo microscope image of the full fracture surface associated with the posterior side of the baseplate.Figures show higher magnification stereo microscope images of the fracture surfaces associated with the posterior and anterior sides of the baseplate, respectively.Based on macroscopic surface features observed, including river lines, the approximate origin location (o) was determined.The fracture origin was observed at or near the laser marking on the baseplate, approximately where the letter ¿z¿ of the size indicator was laser marked mar: review of tibial baseplate, catalogue # 180605, lot code 26050221 confirmed fracture of the baseplate.Characterisation using stereo microscopy and scanning electron microscopy confirmed fracture through the baseplate.The device fractured in fatigue and the fracture initiated at or near the location of laser marking on the baseplate.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient's knee was converted from an mck pka to a competitor tka.Mps reported original suspicion was tibial subsidence.Mps was not present for the revision, but after the case was provided with the explants and the baseplate was broken in half.

• Brand Name: MCK TIBIAL BASEPLATE-LM/RL-SZ 5
• Common Device Name: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer (Section G): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 17347673
• Report Number: 3005985723-2023-00117
• Device Sequence Number: 14718894
• Product Code: NPJ
• UDI-Device Identifier: 00848486000714
• UDI-Public: 00848486000714
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K090763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2023

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: 04/30/2026
• Device Model Number: 180605
• Device Catalogue Number: 180605
• Device Lot Number: 26050221
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2023
• Supplement Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male