MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 3-8MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180703-1

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Unspecified Infection (1930)

Event Date 11/25/2018

Event Type  malfunction  

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.

Event Description

The patient initially gave the informed consent for the mako - unicompartmental knee system test.The patient was later enrolled in the trial.At present, the patient is in the recovery stage on the eighth day after surgery.It was later discovered that the results of blood test were reported: c-reactive protein 38.95ml / l, slight redness around the surgical incision, and slightly higher skin temperature compared with the contralateral side.The possibility of surgical incision infection was considered.

Manufacturer Narrative

The following devices were also listed in this report: mck femoral-rm-ll-sz 2; cat#180512 ; lot# 529576-m mck tibial baseplate-rm/ll-sz 3; cat#180613 ; lot# 26080817-01 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 mako insert was reported.The event was not confirmed.-device evaluation and results: not performed as product was not returned -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 or sterile lot.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, pathology reports, 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 Description

The patient initially gave the informed consent for the mako unicompartmental knee system test.The patient was later enrolled in the trial.At present, the patient is in the recovery stage on the eighth day after surgery.It was later discovered that the results of blood test were reported: c-reactive protein 38.95ml / l, slight redness around the surgical incision, and slightly higher skin temperature compared with the contralateral side.The possibility of surgical incision infection was considered.

• Brand Name: MCK TIBIAL ONLAY INSERT-SZ 3-8MM
• 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: 8195818
• MDR Text Key: 131490320
• Report Number: 3005985723-2018-00772
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486000851
• UDI-Public: 00848486000851
• 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
• Type of Report: Initial,Followup
• Report Date: 02/26/2019

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: 07/31/2022
• Device Catalogue Number: 180703-1
• Device Lot Number: 12160517-1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/26/2018
• Supplement Dates Manufacturer Received: 01/29/2019
• Supplement Dates FDA Received: 02/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 69