MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN_MAKO PKA ROB1298; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number UNK_OFL

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pain (1994); Insufficient Information (4580)

Event Date 03/16/2021

Event Type  Injury  

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.

Event Description

Pka conversion to tka.Off-label / revision.

Event Description

Pka conversion to tka.Off-label/revision.

Manufacturer Narrative

Reported event: an event regarding pain involving a mako pka software was reported.The event was not confirmed because the logs/session files were not available for inspection.Method & results.Product evaluation and results: review of the case session files was not performed as case session data was not provided.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a review of device history records shows that rob1298 was inspected on (b)(6) 2020 and the quality inspection procedures were completed with no reported discrepancies -complaint history review: a review of complaints in trackwise related to p/n 219999, robot number: rob1298 shows 0 similar complaints for pka software - pain.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the case session/log data are needed to complete the investigation for determining root cause.Product surveillance will continue to monitor for trends.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.Device not returned.

Event Description

Pka conversion to tka.Off-label / revision.Update24th march 2021.The patient had a conversion from a medial uni to a tka.The product that was explanted was a stryker product.Rob # 1298.Left.Not available for return.Date of explant (b)(6) 2021.

Manufacturer Narrative

Capture cat # change.Reported event.An event regarding revision involving an unknown mako knee implant 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: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient's pka knee was converted to a tka construct.Reason for revision was not reported.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 primary 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: UNKNOWN_MAKO PKA ROB1298
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 11641736
• MDR Text Key: 244653686
• Report Number: 3005985723-2021-00064
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_OFL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/21/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention