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

Device Problem Fracture (1260)

Patient Problems Fall (1848); Pain (1994)

Event Date 12/11/2023

Event Type  Injury  

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 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 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.

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
• Type of Device: 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18434873
• MDR Text Key: 331863273
• Report Number: 3005985723-2024-00001
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486000776
• UDI-Public: 00848486000776
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 180614
• Device Lot Number: 26500917
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female