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

Catalog Number	180616
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	08/06/2019
Type of Reportable Event	Serious Injury
Additional 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.Device not returned.
Event or Problem Description
Revision of a restoris medial unicompartment knee to a total knee replacement.Patient had a revision undertaken due to pain upon walking.Femoral component appeared well fixed, tibial component was easily moved during the revision.Once implants were removed the tibial implant showed no visible signs of bonding to the cement nor the bone.Femur was well fixed.A total knee replacement was completed satisfactorily using a triathlon ps implant, without delay.
Additional Manufacturer Narrative
An event regarding loosening involving mako baseplate was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as product was not returned -clinician review: a review of the provided medical records by a clinical consultant stated the following comment: rejected for medical review [.] ¿ cannot confirm event, need additional information; primary and revision operative reports, clinical and past medical history.-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 operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Revision of a restoris medial unicompartment knee to a total knee replacement.Patient had a revision undertaken due to pain upon walking.Femoral component appeared well fixed, tibial component was easily moved during the revision.Once implants were removed the tibial implant showed no visible signs of bonding to the cement nor the bone.Femur was well fixed.A total knee replacement was completed satisfactorily using a triathlon ps implant, without delay.

• Brand Name: MCK TIBIAL BASEPLATE-RM/LL-SZ 6
• Common Device Name: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8947010
• Report Number: 3005985723-2019-00626
• Device Sequence Number: 19354821
• Product Code: NPJ
• UDI-Device Identifier: 00848486000790
• UDI-Public: 00848486000790
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K090763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 180616
• Device Lot Number: 26151116-01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2019
• Supplement Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 11/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 105