MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 5-8MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180705-1

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 01/25/2019

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

It was reported through the submission of a revision implant sheet that the patient's left knee was revised.A mako restoris 5x8 onlay tibial insert was implanted.Update 04/february/2019: spoke to rep.An i&d with washout and poly swap was performed due to suspicion of infection (it was not reported to the rep whether the infection was clinically confirmed or not).A 5x8 onlay tibial insert was exchanged for another device of the same catalog number.

Manufacturer Narrative

The following devices were also listed in this report: mck femoral-lm-rl-sz 5; cat# 180505 ; lot# 535896-m; mck tibial baseplate-lm/rl-sz 5; cat# 180605 ; lot# 26071017-01.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An event regarding infection involving a mck tibial onlay insert-sz 5-8mm was reported.The event was not confirmed.Method & results: device evaluation and results: could not be performed as no items associated with the event were returned for evaluation.Medical records received and evaluation: no medical records were received for review with a clinical consultant 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.Conclusions: the source of the infection could not be determined as patient information, clinical history, and results of bloodwork for infection were not provided.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information and/or devices become available, this investigation will be reopened.

Event Description

It was reported through the submission of a revision implant sheet that the patient's left knee was revised.A mako restoris 5x8 onlay tibial insert was implanted.Update 04/february/2019: spoke to rep.An i&d with washout and poly swap was performed due to suspicion of infection (it was not reported to the rep whether the infection was clinically confirmed or not).A 5x8 onlay tibial insert was exchanged for another device of the same catalog number.

• Brand Name: MCK TIBIAL ONLAY INSERT-SZ 5-8MM
• 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: 8361410
• MDR Text Key: 136853907
• Report Number: 3005985723-2019-00187
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486000912
• UDI-Public: 00848486000912
• Combination Product (y/n): N
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 05/07/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 180705-1
• Device Lot Number: 12070917-1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/25/2019
• Initial Date FDA Received: 02/22/2019
• Supplement Dates Manufacturer Received: 04/09/2019
• Supplement Dates FDA Received: 05/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR