MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK FEMORAL-LM-RL-SZ 3; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Model Number	180503
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	05/08/2020
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.Device not returned.
Event or Problem Description
Revised femur of uni pka.Case type:pka (mics).
Event or Problem Description
Revised femur of uni pka.Case type:pka (mics).
Additional Manufacturer Narrative
Update the manufacturing date and expiration date.Reported event: an event regarding loosening involving a mako femoral component was reported.The event was not confirmed.Method & results: -device evaluation and results: visual, functional, dimensional and material inspection not performed as product was not received.-medical records received and evaluation: not performed as medical records were not provided.-device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies -complaint history review: there have been no other similar events for the lot referenced.Conclusion: an event regarding loosening involving a mako uni femoral component was reported.The exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.H3 other text : device not returned.

• Brand Name: MCK FEMORAL-LM-RL-SZ 3
• Common Device Name: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 10105422
• Report Number: 3005985723-2020-00205
• Device Sequence Number: 835051
• Product Code: NPJ
• UDI-Device Identifier: 00848486000554
• UDI-Public: 00848486000554
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2020

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: 06/30/2022
• Device Model Number: 180503
• Device Catalogue Number: 180503
• Device Lot Number: 522932-M
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/08/2020
• Supplement Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 06/01/2020
• Supplement Report FDA Received Date: 09/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 49 YR