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	Osseointegration Problem (3003)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
It was reported that the patient's left knee was revised due to loosening (it was not reported to the rep which device(s) experienced loosening.No possible cause or contributor for loosening was reported to the rep).The patient's mako pka was revised to a total cr knee.Rep provided explant pictures, primary and revision usage sheets, and reported that no further information will be released by the hospital or surgeon.
Event or Problem Description
It was reported that the patient's left knee was revised due to loosening (it was not reported to the rep which device(s) experienced loosening.No possible cause or contributor for loosening was reported to the rep).The patient's mako pka was revised to a total cr knee.Rep provided explant pictures, primary and revision usage sheets, and reported that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
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 inspection of attached images was performed and stated that - blood drops and yellowish material,seems like bone cement can be observed on the explanted images of device.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.Product surveillance will continue to monitor for trends.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.

• 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: 9876914
• Report Number: 3005985723-2020-00176
• Device Sequence Number: 16274823
• Product Code: NPJ
• UDI-Device Identifier: 00848486000554
• UDI-Public: 00848486000554
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K090763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2020

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: 04/30/2022
• Device Model Number: 180503
• Device Catalogue Number: 180503
• Device Lot Number: 508346-M
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 03/25/2020
• Supplement Report FDA Received Date: 04/28/2020
• 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: 52 YR