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

Catalog Number 180603

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/18/2017

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

The surgeon notified that a patient fractured the tibia a month post op.Pka case.This event is for report of patient fracture.

Event Description

The surgeon notified that a patient fractured the tibia a month post op.Pka case.This event is for report of patient fracture.

Manufacturer Narrative

Additional information: product long description, product code, product code,common device name, manufacturer entity, catalog #, lot #; manufacturing site for devices, pma/510(k) #; manufacturing date.An event regarding periprosthetic fracture of the tibia involving a mako baseplate was reported.The event was confirmed.Method & results: device evaluation and results: not performed as product was not returned.Medical records received and evaluation: a review of the provided x-rays by a clinical consultant indicated: "patient trauma or adverse movement during early rehabilitation, although not explicitly reported due to general lack of clinical information have contributed to an acute overload condition with periprosthetic fracture below a restoris unicondylar device with good healing prospects.Not reported whether revision surgery was required." 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.Conclusions: there is no indication that revision surgery has or will take place.As per the clinician's review "patient trauma or adverse movement during early rehabilitation, although not explicitly reported due to general lack of clinical information have contributed to an acute overload condition with periprosthetic fracture below a restoris unicondylar device with good healing prospects." further information such as product return, additional x-rays, operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause no further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: MCK TIBIAL BASEPLATE-LM/RL-SZ 3
• 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: 7164120
• MDR Text Key: 96363192
• Report Number: 0002249697-2018-00046
• 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,other
• Type of Report: Initial,Followup
• Report Date: 03/06/2018

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: 08/30/2021
• Device Catalogue Number: 180603
• Device Lot Number: 26060416-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/10/2017
• Initial Date FDA Received: 01/04/2018
• Supplement Dates Manufacturer Received: 02/07/2018
• Supplement Dates FDA Received: 03/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Weight: 107