MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN_ RESTORIS MCK MEDIAL UKA; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number UNK_OFL

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348); Ambulation Difficulties (2544)

Event Date 01/01/2014

Event Type  Injury  

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 Description

This pi is for the 2014 patellofemoral joint replacement of the patient's left knee.As reported: "this principal investigator performed initial surgery and followed up with patient post-operatively.Information collected on patient reported: arthroscopy (2013) - patient experiencing pain, patellofemoral joint replacement (2014), arthroscopy (2014) - patient experiencing pain, locking, and giving way" patient had a restoris mck medial construct in situ at the time of event.

Manufacturer Narrative

Update to product code, common device name, and g4.Reported event: an event regarding involving instability and pain 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: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.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.H3 other text : device not returned.

Event Description

This pi is for the 2014 patellofemoral joint replacement of the patient's left knee.As reported: "this principal investigator performed initial surgery and followed up with patient post-operatively.Information collected on patient reported: arthroscopy (2013) - patient experiencing pain, patellofemoral joint replacement (2014), arthroscopy (2014) - patient experiencing pain, locking, and giving way" patient had a restoris mck medial construct in situ at the time of event.

• Brand Name: UNKNOWN_ RESTORIS MCK MEDIAL UKA
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 10225094
• MDR Text Key: 197343234
• Report Number: 3005985723-2020-00227
• Device Sequence Number: 1
• Product Code: NPJ
• 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
• Type of Report: Initial,Followup
• Report Date: 10/02/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_OFL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/12/2020
• Initial Date FDA Received: 07/02/2020
• Supplement Dates Manufacturer Received: 09/02/2020
• Supplement Dates FDA Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention