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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 4 - 8 MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
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MAKO SURGICAL CORP. MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 4 - 8 MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM Back to Search Results
Model Number 180734-1
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/07/2020
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.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
 
Event Description
Wrong size onlay tibial insert was inserted into patient.I wrongly grabbed a size 4 insert instead of size 5 and showed boxes to nurse before opening, surgeon refused to look at boxes to confirm.This resulted in wrong size being put in patient.Both assistant and surgeon didn¿t pick up the size difference on insertion and proceeded with closing the incision.While assistant stitched up, surgeon unscrubbed & looked at patient stickers realizing wrong sizes on labels.Surgeon rescrubbed & i grabbed correct size which was inserted and wrong one discarded.Surgical delay of 10 minutes to change the insert.
 
Event Description
Wrong size onlay tibial insert was inserted into patient.I wrongly grabbed a size 4 insert instead of size 5 and showed boxes to nurse before opening, surgeon refused to look at boxes to confirm.This resulted in wrong size being put in patient.Both assistant and surgeon didn¿t pick up the size difference on insertion and proceeded with closing the incision.While assistant stitched up, surgeon unscrubbed & looked at patient stickers realizing wrong sizes on labels.Surgeon rescrubbed & i grabbed correct size which was inserted and wrong one discarded.Surgical delay of 10 minutes to change the insert.
 
Manufacturer Narrative
Reported event: an event regarding user error involving a insert was reported.The event was confirmed based in implant sheet.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 21 sept 2020 with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: no further investigation for this event is possible at this time as no devices and/ or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened h3 other text : device not returned.
 
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Brand Name
MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 4 - 8 MM
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 Key10791537
MDR Text Key214755671
Report Number3005985723-2020-00345
Device Sequence Number1
Product Code NPJ
UDI-Device Identifier00848486016494
UDI-Public00848486016494
Combination Product (y/n)N
PMA/PMN Number
K150307
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 01/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number180734-1
Device Catalogue Number180734-1
Device Lot Number8H455J
Was Device Available for Evaluation? No
Date Manufacturer Received12/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age81 YR
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