MAUDE Adverse Event Report: MAKO SURGICAL CORP. FEM HEAD-COCR 40MM/+7; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	186040-03
Medical Device Problem Codes	Corroded (1131); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Metal Related Pathology (4530)
Date of Event	12/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.H3 other text : device not returned to the manufacturer.
Event or Problem Description
This pi is for the patient's right hip revision.It was reported by an attorney that plaintiff underwent a revision of a hip due to adverse local tissue reaction.
Event or Problem Description
This pi is for the patient's right hip revision.It was reported by an attorney that plaintiff underwent a revision of a hip due to adverse local tissue reaction.
Additional Manufacturer Narrative
Reported event: an event regarding altr involving a metal head 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 with no relevant reported discrepancies.-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 HEAD-COCR 40MM/+7
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19130536
• Report Number: 3005985723-2024-00045
• Device Sequence Number: 6891206
• Product Code: JDI
• UDI-Device Identifier: 00848486009892
• UDI-Public: 00848486009892
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2024

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 Catalogue Number: 186040-03
• Device Lot Number: 140073-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2024
• Supplement Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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