MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 8 - 8 MM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 180738-1

Device Problems Degraded (1153); Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Insufficient Information (4580)

Event Date 09/29/2021

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

It was reported the patient's left medial pka was revised.An 8x8 poly was exchanged for another 8x8 poly.Intra-operatively, appreciable wear was noted on the insert.Rep would like to have the insert investigated upon return and confirmed no further information will be released.

Event Description

It was reported the patient's left medial pka was revised.An 8x8 poly was exchanged for another 8x8 poly.Intra-operatively, appreciable wear was noted on the insert.Rep would like to have the insert investigated upon return and confirmed no further information will be released.

Manufacturer Narrative

Reported event: an event regarding wear involving a mako insert was reported.The event was confirmed via evaluation of the returned device.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device indicated that it is worn.The damage on the articulating surface of the insert is consistent with burnishing, scratching, and third body indentations; which are common damage modes of uhmwpe.The locking edge of the device is fractured; this damage is consistent with explantation / disassembly from the baseplate.-clinician review: no medical records were received for review with a clinical consultant.-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.Conclusions: it was reported that the patient was revised due to a worn insert.Visual inspection of the returned device indicated that it is worn.The damage on the articulating surface of the insert is consistent with burnishing, scratching, and third body indentations; which are common damage modes of uhmwpe.The locking edge of the device is fractured; this damage is consistent with explantation / disassembly from the baseplate.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 8 - 8 MM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: alessandra chavez ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 12690137
• MDR Text Key: 278345360
• Report Number: 3005985723-2021-00170
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 00848486016692
• UDI-Public: 00848486016692
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150307
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: 180738-1
• Device Catalogue Number: 180738-1
• Device Lot Number: KM7DH3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2015
• 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: 81 YR
• Patient Sex: Male