MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-RM/LL-SZ 4; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180614

Device Problem Fracture (1260)

Patient Problems Bone Fracture(s) (1870); Injury (2348)

Event Date 09/11/2018

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.Not returned.

Event Description

Patient called stating she had a right hip replacement 6 years ago.She stated her implant broke inside and had to be revised on (b)(6) 2018.

Event Description

Patient called stating she had a right hip replacement 6 years ago.She stated her implant broke inside and had to be revised on (b)(6) 2018.

Manufacturer Narrative

An event regarding crack/fracture involving a mako baseplate was reported.The event was confirmed.Through clinician review of the surgical protocol.Method & results: product evaluation and results: not performed as no product was returned for evaluation.No photographs were provided for review.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: there are no medical records, x-rays or explant photographs available for the explanted mako device during revision on sep 11, 2018.A fracture of the central portion of the mako tibial baseplate was confirmed in the revision surgical report and as such confirmed although no description of any possible cause was mentioned.The knee was converted to a competitor knee device with short tibial stem extender.Because there are only x-rays post revision after implantation of the competitor knee and no x-rays prior to revision, nor medical records or explant photographs, the cause of failure remains obscure due to lack of relevant information.X-rays of the mako post implantation and post event would be required to help solve this case.Product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: a review of the provided medical records by a clinical consultant stated the following comment: there are no medical records, x-rays or explant photographs available for the explanted mako device during revision on sep 11, 2018.A fracture of the central portion of the mako tibial baseplate was confirmed in the revision surgical report and as such confirmed although no description of any possible cause was mentioned.The knee was converted to a competitor knee device with short tibial stem extender.Because there are only x-rays post revision after implantation of the competitor knee and no x-rays prior to revision, nor medical records or explant photographs, the cause of failure remains obscure due to lack of relevant information.X-rays of the mako post implantation and post event would be required to help solve this case.The exact cause of the event could not be determined because insufficient information was provided.Further information such as device return, pre and post operative x-rays, operative reports as well as patient history and follow up notes are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.The initial event reported an unknown stryker knee.Additional information provided identifies the fractured device as a mako baseplate.Mako devices are reported under registration 3005985723, the registration number cannot be changed, however the legal manufacturer and manufacturing sites have been updated.

• Brand Name: MCK TIBIAL BASEPLATE-RM/LL-SZ 4
• 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: 8066044
• MDR Text Key: 127057070
• Report Number: 0002249697-2018-03716
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 05/29/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: 180614
• Device Lot Number: 26440611-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/23/2018
• Initial Date FDA Received: 11/13/2018
• Supplement Dates Manufacturer Received: 05/01/2019
• Supplement Dates FDA Received: 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 107