MAUDE Adverse Event Report: MAKO SURGICAL CORP. TIBIAL BASEPLATE STD RM/LL SIZE 5; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Model Number 170615

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2022

Event Type  malfunction  

Event Description

It was reported that during a delivering mako instruments, our sales staff noticed a discrepancy of shape (size).There was "rm/ll size 5" but it was actually size 6 shape.

Manufacturer Narrative

Reported event: an event regarding size/fit issue involving a mako baseplate was reported.The event was confirmed via evaluation of the returned device.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device indicated that the device is in undamaged condition.Dimensional inspection performed on the device indicated the dimensions were out of specifications.See attached results.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate 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 lot referenced.Conclusions: it was reported that "during a delivering mako instruments, our sales staff noticed a discrepancy of shape (size) (there was "rm/ll size 5" that was actually size 6 shape".Visual inspection of the returned device indicated that the device is in undamaged condition.Dimensional inspection performed on the device indicated the dimensions were out of specifications.An nc was raised to address this event.Product surveillance will continue to monitor for trends.

Event Description

It was reported that during a delivering mako instruments, our sales staff noticed a discrepancy of shape (size).There was "rm/ll size 5" but it was actually size 6 shape.

Manufacturer Narrative

Reported event: an event regarding size/fit issue involving a mako baseplate was reported.The event was confirmed via evaluation of the returned device.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device indicated that the device is in undamaged condition.Dimensional inspection performed on the device indicated the dimensions were out of specifications.See attached results.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate 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 lot referenced.Conclusions: it was reported that "during a delivering mako instruments, our sales staff noticed a discrepancy of shape (size) (there was "rm/ll size 5" that was actually size 6 shape".Visual inspection of the returned device indicated that the device is in undamaged condition.Dimensional inspection performed on the device indicated the dimensions were out of specifications.Nc was raised to address this event.A classification letter from the fda has not been received; once the classification letter is received, a supplemental will be sent with the recall number.

• Brand Name: TIBIAL BASEPLATE STD RM/LL SIZE 5
• 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: kelsey williams ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16385250
• MDR Text Key: 309649369
• Report Number: 3005985723-2023-00035
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486003746
• UDI-Public: 00848486003746
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 170615
• Device Catalogue Number: 170615
• Device Lot Number: 26270421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: PFA 3194049
• Patient Sequence Number: 1
• Patient Outcome(s): Other