MAUDE Adverse Event Report: MAKO SURGICAL CORP. ACE SHELL-CLUST HOLE POR-48MM IMPLANT; HIP PROSTHESIS, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER, + ADDITIVE, POROUS,

Catalog Number	186002-48
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: cat# 186132-48; device description: ace linr-e-poly neut-32/48 implant; lot# 191531-01 it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
Surgeon performed a full implant extraction and i&d of a right hip due to infection.Surgeon implanted an exeter cup and stem as an antibiotic spacer.Revision, infection.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Reported event: an event regarding infection involving a mako 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: no medical records were received for review with a clinical consultant.-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 and sterile lot referenced.Conclusions: it was reported that the surgeon performed a full implant extraction and i&d of a right hip due to infection.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: ACE SHELL-CLUST HOLE POR-48MM IMPLANT
• Common Device Name: HIP PROSTHESIS, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER, + ADDITIVE, POROUS,
• 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: deepan raju srinivasan ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24267957
• Report Number: 3005985723-2026-00052
• Device Sequence Number: 9947957
• Product Code: OQG
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K112802
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2026

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: 07/31/2020
• Device Catalogue Number: 186002-48
• Device Lot Number: 031537-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2015
• 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 Age: 70 YR
• Patient Sex: Female