MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK PATELLOFEMORAL-L-SZ 3; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY

Catalog Number 180403

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348)

Event Date 05/24/2019

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

It was reported that the patient's left knee (patellofemoral component) was revised after patient complaint of pain, 7 months post robotic procedure.Patient was revised to a stryker total knee.The rep reported that no further information is available.

Manufacturer Narrative

An event regarding pain involving a mako femoral component was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: no medical records were received for review with a clinical consultant.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: 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.

Event Description

It was reported that the patient's left knee (patellofemoral component) was revised after patient complaint of pain, 7 months post robotic procedure.Patient was revised to a stryker total knee.The rep reported that no further information is available.

• Brand Name: MCK PATELLOFEMORAL-L-SZ 3
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8712494
• MDR Text Key: 148432848
• Report Number: 3005985723-2019-00444
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486000417
• UDI-Public: 00848486000417
• Combination Product (y/n): N
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 08/07/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 180403
• Device Lot Number: 2607611-1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/24/2019
• Initial Date FDA Received: 06/19/2019
• Supplement Dates Manufacturer Received: 07/10/2019
• Supplement Dates FDA Received: 08/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 44 YR
• Patient Weight: 125