MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-LM/RL-SZ 6; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180606

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 04/17/2019

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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

During the cementing of the final implants, dr.Suspected a potential fracture in the tibia.He made a comment about the blue tip breaking off of the tibial baseplate impactor while he was sliding the impactor from the posterior part of the baseplate to anterior and that some of the final impactions may have been metal on metal.He put in the femoral and insert trials and placed the leg in extension with an axial load to fully seat the cemented tibia baseplate rather than continue to use an impactor.He noticed the tibial checkpoint seemed loose and was easily able to pull it out.Once removed, he was able to confirm there was a fracture and ordered an x-ray.An x-ray confirmed a fracture from the tibia plateau extending to where the position of the tibia checkpoint was seated.Dr.Suspects the fracture propagated at the tibial keel and worked its way anterior to the lateral side of the peg and down to the checkpoint, although he was not able to confirm it went to the keel because the implant was already cemented down.A trauma surgeon was called in to repair the fracture.Following this, alignment was checked in kinematic analysis as well as walking the green probe over the baseplate in the implant planning page.Dr.Was still happy with the alignment and final numbers, noting that we may have lost roughly 0.5-1 degree of varus due to the fracture.The leg alignment with trials was 4-4.5 degrees varus and the post-fracture was 5-5.5 degrees of varus, corrected from an original native deformity of 7-7.5 degrees of varus.An additional comment was made following the case that warm cement was used, which is not commonly his preference, which may have rushed the process of cementing the final implants.Case type: tka, surgical delay 30-60 minutes, this complaint is for the tibial impactor and tibial baseplate.Update: patient was under anesthesia and delay of surgery approximately one hour.

Manufacturer Narrative

An event regarding intraoperative periprosthetic fracture involving a mako baseplate was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as product remains implanted.-clinician review: a review of the provided medical record by a clinical consultant indicated: "cannot confirm event, need additional information; primary and revision operative reports, clinical and past medical history, additional serial x-rays." -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 primary and revision operative reports, clinical and past medical history, additional serial x-rays 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

During the cementing of the final implants, dr.Suspected a potential fracture in the tibia.He made a comment about the blue tip breaking off of the tibial baseplate impactor while he was sliding the impactor from the posterior part of the baseplate to anterior and that some of the final impactions may have been metal on metal.He put in the femoral and insert trials and placed the leg in extension with an axial load to fully seat the cemented tibia baseplate rather than continue to use an impactor.He noticed the tibial checkpoint seemed loose and was easily able to pull it out.Once removed, he was able to confirm there was a fracture and ordered an x-ray.An x-ray confirmed a fracture from the tibia plateau extending to where the position of the tibia checkpoint was seated.Dr.Suspects the fracture propagated at the tibial keel and worked its way anterior to the lateral side of the peg and down to the checkpoint, although he was not able to confirm it went to the keel because the implant was already cemented down.A trauma surgeon was called in to repair the fracture.Following this, alignment was checked in kinematic analysis as well as walking the green probe over the baseplate in the implant planning page.Dr.Was still happy with the alignment and final numbers, noting that we may have lost roughly 0.5-1 degree of varus due to the fracture.The leg alignment with trials was 4-4.5 degrees varus and the post-fracture was 5-5.5 degrees of varus, corrected from an original native deformity of 7-7.5 degrees of varus.An additional comment was made following the case that warm cement was used, which is not commonly his preference, which may have rushed the process of cementing the final implants.Case type: tka.Surgical delay 30-60 minutes.This complaint is for the tibial impactor and tibial baseplate.Update: patient was under anethesia and delay of surgery approximately one hour.

• Brand Name: MCK TIBIAL BASEPLATE-LM/RL-SZ 6
• 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: 8608735
• MDR Text Key: 145001302
• Report Number: 3005985723-2019-00361
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486000721
• UDI-Public: 00848486000721
• Combination Product (y/n): N
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 180606
• Device Lot Number: 26321017-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR