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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. FEMORAL TEMPLATE STD LM/RL SIZE 1; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
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MAKO SURGICAL CORP. FEMORAL TEMPLATE STD LM/RL SIZE 1; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM Back to Search Results
Model Number 160141
Device Problem Inaccurate Information (4051)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 11/26/2019
Event Type  malfunction  
Manufacturer Narrative
As part of the normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.
 
Event Description
As reported by a mako product manager: "if we are not wrong, we noticed a mistake of translation for the mako restoris size 1 femoral trial ref 160141.In english it¿s lm/rl while the translation in french means internal right/external left."a.Pdf supplied of the label appears to be a sample label, not a packaging label.It is unknown if any physical labels/ devices are involved at this time.
 
Event Description
As reported by a mako product manager: "if we are not wrong, we noticed a mistake of translation for the mako restoris size 1 femoral trial ref 160141.In english it¿s lm/rl while the translation in french means internal right/external left."a.Pdf supplied of the label appears to be a sample label, not a packaging label.It is unknown if any physical labels/ devices are involved at this time.
 
Manufacturer Narrative
An event regarding label content involving a mako guide was reported.The event was confirmed based on evaluation of the approved label design.Method & results: -device evaluation and results: not performed as the reported event is related to general label content for catalog # 160141, not lot specific.-clinician review: not performed as the reported event is related to general label content for catalog # 160141, not lot specific.-device history review: not performed as the reported event is related to general label content for catalog # 160141, not lot specific.-complaint history review: not performed as the reported event is related to general label content for catalog # 160141, not lot specific.Conclusion: no physical devices with labels were provided.An approved label design was provided for review.There is a mistake of translation for the mako restoris size 1 femoral trial ref (b)(4).In english it¿s lm/rl while the translation in french means internal right/external left.The reported event was confirmed.Nc was issued on 31-jan-2020 for restoris mck femoral template (size 1 lm/rl) incorrect french translation.The investigation conducted confirmed there was a translation error for the mako restoris size 1 femoral trial ref (b)(4).In english it¿s lm/rl while the translation in french means internal right/external left.An nc was issued for restoris mck femoral template (size 1 lm/rl) incorrect french translation.A severity of harm assessment was conducted and the highest potential harm was determined to be an s1 for complications associated with extended surgery of less than or equal to 15 minutes to verify the correct translation on the product label and replace with the correct template.Based on the risk review conducted, this event was determined to be a non-reportable incident.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
 
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Brand Name
FEMORAL TEMPLATE STD LM/RL SIZE 1
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 Key9513167
MDR Text Key175876261
Report Number3005985723-2019-00918
Device Sequence Number1
Product Code NPJ
UDI-Device Identifier00848486020163
UDI-Public00848486020163
Combination Product (y/n)N
PMA/PMN Number
K090763
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup
Report Date 03/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number160141
Device Catalogue Number160141
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received02/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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