MAUDE Adverse Event Report: MAKO SURGICAL CORP. FEM STEM-HI OFFSET NK-SIZE 8 IMPLANT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 186004-08

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body Reaction (1868)

Event Date 06/20/2018

Event Type  Injury  

Manufacturer Narrative

As part of the 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 : not available.

Event 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 left hip revision.

Event 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 left hip revision.

Manufacturer Narrative

Reported event: an event regarding altr involving a mako stem was reported.The event was confirmed.Through a review of provided medical records with a clinical consultant.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: a review of the provided medical records with a clinical consultant indicated: "conclusion/assessment: 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." product history review: review of the device history records indicate devices were manufactured and accepted into final stock.Complaint history review: there have been no other similar events for the lot referenced.Conclusion: it was reported that the patient's left hip was revised due to adverse local tissue reaction.A review of the provided medical records with a clinical consultant indicated: "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." the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays 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: FEM STEM-HI OFFSET NK-SIZE 8 IMPLANT
• Type of Device: 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19104329
• MDR Text Key: 340136304
• Report Number: 3005985723-2024-00042
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00848486008109
• UDI-Public: 00848486008109
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/15/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 186004-08
• Device Lot Number: 100060-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/15/2024
• 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): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male