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
Medical Device Problem Codes	Degraded (1153); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bacterial Infection (1735); Insufficient Information (4580)
Date of Event	09/29/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3005985723-2021-00170
• Device Sequence Number: 4985822
• Product Code: HRY
• UDI-Device Identifier: 00848486016692
• UDI-Public: 00848486016692
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K150307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2022

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: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2021
• Supplement Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 10/25/2021
• Supplement Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2015
• 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: 81 YR
• Patient Sex: Male