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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 5-8MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
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MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 5-8MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM Back to Search Results
Model Number 180705-1
Device Problem Fracture (1260)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/28/2020
Event Type  malfunction  
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.Device not returned.
 
Event Description
It was reported by the distributor that surgeon was about to implant the insert as usual.However, upon impact, the insert did not appear to sit very well on the tibia tray.Hence, the surgeon further examine and realise the insert has cracked.Hence, he requested for another new insert while attempt to remove the cracked insert.This is the primary surgery.Surgery delayed for 5 to 10mins.Hospital: sgh, case no: (b)(4).Catalog number : 180705-1.Lot / serial number : (b)(4).Product is available for return for investigation.
 
Event Description
It was reported by the distributor that surgeon was about to implant the insert as usual.However, upon impact, the insert did not appear to sit very well on the tibia tray.Hence, the surgeon further examine and realise the insert has cracked.Hence, he requested for another new insert while attempt to remove the cracked insert.This is the primary surgery.Surgery delayed for 5 to 10mins.
 
Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a mako insert was reported.The event was confirmed based on inspection.Method & results: -product evaluation and results:visual inspection: the device was returned in used condition.Scratch marks and dent can be seen on the surface of an insert.Refer attached pics ma: damage observed on the insert consistent with attempted implantation.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined dimensional inspection: not performed as the dimensional aspects are not in question.Functional inspection: not performed as the functional aspects are not in question.-clinician review: not performed as no medical records were received for review with a clinical consultant.-product history review: indicated 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 lot or sterile lot referenced.Conclusion: it was reported by the distributor that surgeon was about to implant the insert as usual.However, upon impact, the insert did not apppear to sit very well on the tibia tray.Hence, the surgeon further examine and realise the insert has cracked.The event was confirmed based on inspection.The device was returned in used condition.Scratch marks and dent can be seen on the surface of an insert.Refer attached pics ma: damage observed on the insert consistent with attempted implantation.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays are needed to fully investigate the event.If further information becomes available , this investigation will be re-opened.
 
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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 Key10443225
MDR Text Key204226930
Report Number3005985723-2020-00274
Device Sequence Number1
Product Code NPJ
UDI-Device Identifier00848486000912
UDI-Public00848486000912
Combination Product (y/n)N
PMA/PMN Number
K090763
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 10/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/07/2022
Device Model Number180705-1
Device Catalogue Number180705-1
Device Lot Number12060217-1
Was Device Available for Evaluation? No
Date Manufacturer Received09/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
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