MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK PATELLA RESURFACING ROUND DOME-32MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number	180320-3
Medical Device Problem Codes	Degraded (1153); Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported: "revision of a pfj due to patella wear.Initial case done (b)(6) 2018.Patella flaked and worn #".
Additional Manufacturer Narrative
Reported event: an event regarding wear involving a mako patella was reported.The event was confirmed through visual inspection of the provided photos.Method & results: -device evaluation and results: visual inspection: the reported device was not returned however photographs were provided for review.The photographs show a recently explanted mako patella.From the photographs provided there is evidence of biological matter and the patella appears worn and there are material fragments present, most likely as a result of explantation.Material analysis, 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.-device history review: review of the product history records indicate the reported device was manufactured with no reported relevant discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusion: it was reported that the patient was revised, 'revision of a pfj due to patella wear.' the reported device was not returned however photographs were provided for review.The photographs show a recently explanted mako patella.From the photographs provided there is evidence of biological matter and the patella appears worn and there are material fragments present, most likely as a result of explantation.No further investigation for this event is possible at this time.If device/additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
No new information.

• Brand Name: MCK PATELLA RESURFACING ROUND DOME-32MM
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 22919807
• Report Number: 3005985723-2025-00401
• Device Sequence Number: 18699680
• Product Code: NPJ
• UDI-Device Identifier: 00848486000363
• UDI-Public: 00848486000363
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K112507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2026

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: 08/12/2021
• Device Catalogue Number: 180320-3
• Device Lot Number: 12020816-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2016
• 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: 50 YR
• Patient Sex: Female