MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK PATELLA RESURFACING ROUND DOME-29MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number	180320-2
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Surgeon completed revision procedure and noted significant wear on the patella component (explanted on date of surgery).
Additional Manufacturer Narrative
This event was originally reported to stryker as an unknown device and submitted to fda under mfr# 0002249697-2024-01623.This report is being filed to correct the change in catalog information, fda registration number and additional information.Reported event: an event regarding wear involving a mako patella was reported.The event was confirmed.Method & results: device evaluation and results: visual inspection: visual inspection of the returned device indicated that the patella is worn.Cement is present on the device as well.The damage present on the anterior and posterior surfaces is consistent with delamination and material loss.The damage on the articulating surface of the patella is consistent with burnishing, scratching, and third body indentations, which are common damage modes of uhmwpe.Dimensional inspection: dimensional inspection for the device was not performed as the device was returned damaged.Functional inspection: functional inspection for the device was not performed as the device was returned damaged.Clinician review: a review of the provided medical records by a clinical consultant indicated: "i have reviewed the documentation provided including the product inquiry cover sheet, and ap lateral and sunrise view x-rays of a patellofemoral arthroplasty.Event description: surgeon completed revision procedure and noted significant wear on the patella component (explanted on date of surgery).The x-rays provided show a cemented patellofemoral arthroplasty in anatomic position without evidence of mechanical complication.No documentation regarding revision surgery was provided.Should further documentation become available i would be happy to further this investigation.Device history review: a review of the device history records could not be performed as lot code information was unknown.Complaint history review: there have been no other similar events for the lot referenced.Conclusion: it was reported that the patient was revised, reason unknown.The device was returned; visual inspection of the returned device indicated that the patella is worn.Cement is present on the device as well.The damage present on the anterior and posterior surfaces is consistent with delamination and material loss.The damage on the articulating surface of the patella is consistent with burnishing, scratching, and third body indentations, which are common damage modes of uhmwpe.A review of the provided medical records by a clinical consultant indicated: "i have reviewed the documentation provided including the product inquiry cover sheet, and ap lateral and sunrise view x-rays of a patellofemoral arthroplasty.Event description: surgeon completed revision procedure and noted significant wear on the patella component (explanted on date of surgery).The x-rays provided show a cemented patellofemoral arthroplasty in anatomic position without evidence of mechanical complication.No documentation regarding revision surgery was provided.Should further documentation become available i would be happy to further this investigation.' 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.

• Brand Name: MCK PATELLA RESURFACING ROUND DOME-29MM
• 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: alessandra chavez ; 3365 enterprise ave; weston, FL 33331 ; 9546280700
• MDR Report Key: 21584495
• Report Number: 3005985723-2025-00099
• Device Sequence Number: 9276166
• Product Code: NPJ
• UDI-Device Identifier: 00848486000349
• UDI-Public: 00848486000349
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/12/2025

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: 180320-2
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Female