MAUDE Adverse Event Report: MAKO SURGICAL CORP. FEMORAL/TIBIAL CHECKPOINT KIT -(STERILE); STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 111645

Device Problems Break (1069); Non Reproducible Results (4029)

Patient Problem Bone Fracture(s) (1870)

Event Date 04/17/2019

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.

Event Description

During the cementing of the final implants, dr.(b)(6) 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.(b)(6) 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.Dr.(b)(6), 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.(b)(6) 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: pka.Surgical delay: 30-60 minutes.This complain is for the tibia checkpoint.

Manufacturer Narrative

Reported event: during the cementing of the final implants, dr.Haas 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.Haas 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.Dr.Ricci, 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.Haas 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.Product evaluation and results: product inspection could not be performed as the product was not returned for evaluation.Product history review: product history review could not be conducted as the l/n is not provided.Complaint history review: complaint history review could not be conducted as the l/n is not provided.Conclusions: no additional investigation or specific actions are required.¿ corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been no ncs and capas associated with the product and failure mode reported in this event.H3 other text : product was not available for evaluation.

Event Description

During the cementing of the final implants, dr.(b)(6) 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.Haas 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.Dr.(b)(6), 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.Haas 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: pka.Surgical delay: 30-60 minutes.This complain is for the tibia checkpoint.

• Brand Name: FEMORAL/TIBIAL CHECKPOINT KIT -(STERILE)
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8574156
• MDR Text Key: 143849809
• Report Number: 3005985723-2019-00339
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486029494
• UDI-Public: 00848486029494
• Combination Product (y/n): N
• PMA/PMN Number: K143752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 111645
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR