MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 4-8MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number	180704-1
Medical Device Problem Codes	Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/02/2024
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 if additional information becomes available.The following devices were also listed in this report: device name#mako lm femoral component ; cat#unknown; lot#unknown device name#mck tibial baseplate-lm/rl-sz 4 ; cat#180604; lot# let 1636210813.Device name#mck patellofemoral-l-sz 4 ; cat#180404; lot#26190412-01.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Left knee revision done due to lateral joint pain in the knee.
Additional Manufacturer Narrative
Reported event: an event regarding wear involving a mako insert was reported.The event was confirmed.Method & results:  device evaluation and results: visual inspection: the device was not returned; however, photographs were provided for review.The photos show a recently explanted insert with with signs of wear.Clinician review: no medical records were received for review with a clinical consultant.Device history review: not performed as the lot number is unknown.Complaint history review: not performed as the lot number is unknown.Conclusion: it was reported that the patient was revised due to pain.The device was not returned; however, photographs were provided for review.The photos show a recently explanted insert with with signs of wear.A review of the provided medical records by a clinical consultant indicated: "very little clinical information was provided for review.No preoperative or postoperative records were provided.No preoperative or postoperative radiographs were provided.The pi event reports a revision of a bicondylar mako knee replacement (medial and patella-femoral).The reason for revision was stated as lateral knee pain.X-rays do not show significant lateral joint pathology, but a flexion view was not provided for review.The preoperative evaluation, intraoperative findings and outcome of the surgery were not provided for review.Event confirmation: the event, a revision knee surgery, cannot be confirmed without additional medical information.Root cause: the root cause of the revision was stated as lateral joint pain.The event was not confirmed thus a root cause cannot be ascertained." no further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Left knee revision done due to lateral joint pain in the knee.Update - apr 18, 2024- investigation of device images showed wear on both the tibial insert and the patella.

• Brand Name: MCK TIBIAL ONLAY INSERT-SZ 4-8MM
• Common Device Name: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• 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: 18567451
• Report Number: 3005985723-2024-00013
• Device Sequence Number: 15156186
• Product Code: NPJ
• UDI-Device Identifier: 00848486000882
• UDI-Public: 00848486000882
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K082172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2024

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: 180704-1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/02/2024
• Supplement Date Received by Manufacturer: 04/19/2024
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 05/14/2024
• 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: 59 YR
• Patient Sex: Female