MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN RESTORIS LATERAL INSERT - PKA 3.0 2.8MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number UNK_OFL

Device Problem Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 02/23/2023

Event Type  Injury  

Event Description

Dr.Informed that he performed a mako lateral partial knee replacement on patient about 3.5 years ago.The patient was complaining of pain and he performed a scope yesterday on (b)(6) 2023 and noticed the tibial poly is "stained brown, it's pitting and when you look at it from the front you can see it's not flat and shows some concavity where the brown spot is".He also informed he found a chondral lesion on the patient's mfc.He stated that this implant has only been in for 3 1/2 years and this really shouldn't' happen.The scope he performed yesterday was due to the patient's continued pain.Case type / application: pka (mics) "right lateral".

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 if additional information becomes available.Catalog numbers and lot codes of other devices listed in this report: size 1 lm/rl femur lot - unknown.Size 2 lm/rl tibial baseplate lot -unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

• Brand Name: UNKNOWN RESTORIS LATERAL INSERT - PKA 3.0 2.8MM
• Type of Device: 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 16574234
• MDR Text Key: 311654404
• Report Number: 3005985723-2023-00058
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female