MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKO ROBOTIC ARM 3.1; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	219999
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a l tha we passed the acetabulum registration but at the end the xray showed a cup which looked misplaced.Case type: tha 4.0.
Additional Manufacturer Narrative
Reported event an event regarding incorrect placement involving a mako robotic arm was reported.The event was not confirmed.Method & results -product evaluation and results: a request for a field service engineer inspection was not made and the robot was not inspected.-clinician review: a review of the provided medical information by a clinical consultant indicated: this x-ray consists of a single screenshot from a cell phone.It is undated.It shows an x-ray of the pelvis.The x-ray shows a left total hip arthroplasty in place.There is a short stem femoral component.There is a cementless acetabular component.Position and fixation of both components appear satisfactory, although the offset on the left has been increased.On this view the acetabular component is in neutral version.Confirmation of event: i can confirm that the patient had a left total hip arthroplasty since i was able to review an x-ray with a total hip arthroplasty in place.Icannot confirm the information regarding abnormal appearance of the cup since i have no x-ray evidence of any "weird" looking appearance.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of an abnormal appearing acetabular component are multi factorial.Factors include surgical technique including the method of determination of cup position and inadequate registration of the robotic program for the acetabulum.I would not assign any causality to the patient or the acetabular implant.-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 are no other complaints with a similar failure mode for this lot.Conclusions: the alleged failure mode was not confirmed through a clinician review of the provided x-ray.Additionally there was no information provided by the complainant.If a field service inspection is requested, further investigation will be completed on this issue.Additionally, a complaint history review provides no indication of any inherent software/ hardware issue.No additional investigation or specific actions are required.If additional information is received, then the complaint will be reopened.
Event or Problem Description
No new information.

• Brand Name: MAKO ROBOTIC ARM 3.1
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• 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: sanjana talathi ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23848621
• Report Number: 3005985723-2025-00625
• Device Sequence Number: 9836017
• Product Code: OLO
• UDI-Device Identifier: 07613327395280
• UDI-Public: 07613327395280
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 219999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/09/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male