MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-RM/LL-SZ 4; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number	180614
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Pain (1994)
Date of Event	12/11/2023
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 if additional information becomes available.H3 other text : device not returned to the manufacturer.
Event or Problem Description
Had a revision of a possible loose or broken mako uni baseplate after the patient complained of pain after falling.Once the surgeon got into the joint he confirmed the metal baseplate was broken in half.
Event or Problem Description
Had a revision of a possible loose or broken mako uni baseplate after the patient complained of pain after falling.Once the surgeon got into the joint he confirmed the metal baseplate was broken in half.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a mako baseplate was reported.The event was confirmed via provided photographs of the device.Method & results: product evaluation and results: the reported device was not returned; however photographs were provided for review.The photographs show that the baseplate has fractured in half down the middle.Clinician review: a review of the provided medical information by a clinical consultant indicated: "this product inquiry concerns, a patient, who underwent a unicompartmental replacement of the knee, and then suffered a fall, and then complained of pain.Upon revision a fracture of the base plate was found.I can confirm that the patient underwent the primary procedure since i was able to see an x-ray with the implant in place.I cannot definitely confirm the revision since i was only able to see photographs of the fractured base plate.I do not have any other documentation such as operation report, doctors notes or post revision x-rays.The causes of baseplate fracture are multifactorial including surgical technique, especially ligament balancing, alignment and cementing technique.In this particular case i did not see very much in the way of cement below the base plate.If one side of the base plate was preferentially cemented theoretically a cantilever effect can occur which can contribute to breakage.Also in this particular case the patient sustained a fall so that the fracture could be considered post-traumatic.Also contributing causes include the patient's activity level and bmi as well as implant factors." product 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.Conclusions: it was reported that the patient was revised due to fracture of the tibial baseplate.The reported device was not returned; however photographs were provided for review.The photographs show that the baseplate has fractured in half down the middle.Clinician review of the provided x-ray images indicated the following: "the causes of baseplate fracture are multifactorial including surgical technique, especially ligament balancing, alignment and cementing technique.In this particular case i did not see very much in the way of cement below the base plate.If one side of the base plate was preferentially cemented theoretically a cantilever effect can occur which can contribute to breakage.Also in this particular case the patient sustained a fall so that the fracture could be considered post-traumatic.Also contributing causes include the patient's activity level and bmi as well as implant factors." no further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: MCK TIBIAL BASEPLATE-RM/LL-SZ 4
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18434873
• Report Number: 3005985723-2024-00001
• Device Sequence Number: 12500165
• Product Code: NPJ
• UDI-Device Identifier: 00848486000776
• UDI-Public: 00848486000776
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K082172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2024

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: 04/30/2023
• Device Catalogue Number: 180614
• Device Lot Number: 26500917
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2018
• 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: Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female