MAUDE Adverse Event Report: MAKO SURGICAL CORP. TRIDENTII TRITANIUM CLUSTER46C; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	702-04-46C
Medical Device Problem Codes	Failure to Advance (2524); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During mako tha case, surgeon commented that there had been a small fracture to the posterior acetabulum.Mako plan was originally discussed and showed surgeon plan with 46 cup, surgeon asked, if possible, to upsize cup, showed bigger size and said not an appropriate option due to being oversized, surgeon happy to continue with 46 cup plan, well sized.Reaming had been completed with mako as per usual, when trying to impact with mako, surgeon was having trouble getting cup into position, was reporting that the patient has extensive soft tissue and was having trouble getting mako reaming handle into position.At this point had rechecked pelvic checkpoint and tool checkpoint and both had passed.Surgeons stated that he did not want to extend incision to help access, surgeon happy to try offset impactor mako handle.Changed to offset impaction handle and checked tool checkpoint which passed, but surgeon still having issues with access and getting mako impaction handle into good position, stating that patient soft tissue was pushing off plane.Surgeon decided to manually impact without mako impaction handle.Surgeon manually impacted and then checked surgical results with blue probe, surgeon was not happy with surgical results numbers and position of cup so moved cup and re impacted 4 times.Surgeon then put one screw in cup and then impacted liner, at this point surgeon commented that there was a small fracture in the posterior wall of acetabulum.Continued with case.
Additional Manufacturer Narrative
Correction of "manufacturing site for devices" field.Reported event: an event regarding intraoperative fracture involving a trident ii shell 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 was not returned -clinician review: insufficient information was provided to support a medical review.-product history review: review of the product history records indicate the reported device was manufactured with no reported relevant discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that 'during mako tha case, surgeon commented that there had been a small fracture to the posterior acetabulum.Mako plan was originally discussed and showed surgeon plan with 46 cup, surgeon asked if possible to upsize cup, showed bigger size and said not an appropriate option due to being oversized, surgeon happy too continue with 46 cup plan, well sized.Reaming had been completed with mako as per usual, when trying to impact with mako, surgeon was having trouble getting cup into position, was reporting that the patient has extensive soft tissue and was having trouble getting mako reaming handle into position.At this point had re checked pelvic checkpoint and tool checkpoint and both had passed.Surgeons stated that he did not want to extend incision to help access, surgeon happy to try offset impactor mako handle.Changed to offset impaction handle and checked tool checkpoint which passed, but surgeon still having issues with access and getting mako impaction handle into good position, stating that patient soft tissue was pushing off plane.Surgeon decided to manually impact without mako impaction handle.Surgeon manually impacted and then checked surgical results with blue probe, surgeon was not happy with surgical results numbers and position of cup so moved cup and re impacted 4 times.Surgeon then put one screw in cup and then impacted liner, at this point surgeon commented that there was a small fracture in the posterior wall of acetabulum.Continued with case.' the exact cause of the event could not be determined because insufficient information was provided.Further information such as the primary operative report and/or photographs/video of the reported event are needed to complete the investigation for determining root cause.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.
Event or Problem Description
No new information.

• Brand Name: TRIDENTII TRITANIUM CLUSTER46C
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NJ NA ; EI NA
• Manufacturer Contact: sanjana talathi ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22478214
• Report Number: 0002249697-2025-00691
• Device Sequence Number: 7942991
• Product Code: LPH
• UDI-Device Identifier: 07613327343809
• UDI-Public: 07613327343809
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K171768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2025

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 Catalogue Number: 702-04-46C
• Device Lot Number: 19041551A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/13/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2024
• 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: Other
• Patient Age: 38 YR
• Patient Sex: Female