MAUDE Adverse Event Report: MAKO SURGICAL CORP. FEM STEM-HI OFFSET NK-SIZE 9 IMPLANT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	186004-09
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Date of Event	12/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding altr involving a mako stem was reported.The event was confirmed through medical review.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.-clinician review: a patient underwent bilateral staged tha for oa.The procedures used restoris components, but use of the robot was not described in the op notes.Pins were noted in the or leger.The patient ultimately underwent staged bilateral revisions for altr.The right side was symptomatic, the left side was not (but had radiographic findings).No pre or postoperative records were provided for review, no laboratory values or radiographs were provided for review.-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.Conclusion: a patient underwent bilateral staged tha for oa.The procedures used restoris components, but use of the robot was not described in the op notes.Pins were noted in the or leger.The patient ultimately underwent staged bilateral revisions for altr.The right side was symptomatic, the left side was not (but had radiographic findings).No pre or postoperative records were provided for review, no laboratory values or radiographs were provided for review.Event confirmation: primary tha and revision arthroplasty can be confirmed.The description of the intraoperative findings would point to altr with pseudotumor, but pathology confirmation was not provided.Trunnionosis was only described for the right side.Concomitant infection cannot be confirmed.Root cause: the root cause for the revision surgery was pain on the right and signs of altr with fluid collection and pseudo tumor on the right and left.Additional information, including pathology reports, progress notes, x-rays, follow up notes and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
It was reported by an attorney that plaintiff underwent a revision of a hip due to adverse local tissue reaction.This pi is for the patient's right hip revision.

• Brand Name: FEM STEM-HI OFFSET NK-SIZE 9 IMPLANT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19179140
• Report Number: 3005985723-2024-00051
• Device Sequence Number: 7431499
• Product Code: JDI
• UDI-Device Identifier: 00848486008123
• UDI-Public: 00848486008123
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112802
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/25/2024

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: 10/31/2017
• Device Catalogue Number: 186004-09
• Device Lot Number: 100022-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2012
• 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: 69 YR
• Patient Sex: Male