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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRIATHLON BASEPLATE; UNKNOWN KNEE IMPLANT
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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRIATHLON BASEPLATE; UNKNOWN KNEE IMPLANT Back to Search Results
Catalog Number 5531G409
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Pain (1994); Injury (2348)
Event Date 10/23/2018
Event Type  Injury  
Manufacturer Narrative
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.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
 
Event Description
It was reported that patient's left knee was revised due to pain.Surgeon reported that the tilt of the tibial cut was too strong (too much slope).All components were well fixed.Surgeon decided to revise the 4x9 cs insert to a 4x11 cs insert.
 
Manufacturer Narrative
Correction: through the process of investigation it was discovered that the subject device for this event is an unknown tibial baseplate and not the tibial insert as first reported.Therefore, the catalog, lot, gtin, manufacture date, expiration date and 510k are all unknown.An event regarding revision due to malposition of an unknown triathlon baseplate was reported.The event was confirmed based on clinician review of the medical records.Method & results: -device evaluation and results: not performed as product was not returned - the baseplate remains implanted.-medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: the event description states, ¿¿ left knee revised due to pain ¿ tilt of the tibial component was too strong ¿ all components well fixed ¿ decided to revise 4/9 cs insert to 4/11 cs insert.¿ no clinical or past medical history, no revision operative report or description of findings, no serial dated x-rays and no examination of the explanted insert is available.If, as suggested in the event description, the ¿tibial cut was too strong¿, perhaps difficulty with the orthoalign navigation system was involved.There is no evidence that factors associated with implant design, manufacturing, or materials were responsible for this revision surgery six months after implantation.-device history review: could not be performed as lot code information was not provided.-complaint history review: could not be performed as lot code information was not provided.Conclusions: a review of the provided medical records and x-rays by a clinical consultant indicated: the event description states, ¿¿ left knee revised due to pain ¿ tilt of the tibial component was too strong ¿ all components well fixed ¿ decided to revise 4/9 cs insert to 4/11 cs insert.¿ no clinical or past medical history, no revision operative report or description of findings, no serial dated x-rays and no examination of the explanted insert is available.If, as suggested in the event description, the ¿tibial cut was too strong¿, perhaps difficulty with the orthoalign navigation system was involved.There is no evidence that factors associated with implant design, manufacturing, or materials were responsible for this revision surgery six months after implantation.Further information such as clinical and past medical history, revision operative report including the description of findings, serial dated x-rays and examination of the explanted insert are needed to complete the investigation for determining root cause.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
 
Event Description
It was reported that patient's left knee was revised due to pain.Surgeon reported that the tilt of the tibial cut was too strong (too much slope).All components were well fixed.Surgeon decided to revise the 4x9 cs insert to a 4x11 cs insert.
 
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Brand Name
UNKNOWN TRIATHLON BASEPLATE
Type of Device
UNKNOWN KNEE IMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key8086929
MDR Text Key127806881
Report Number0002249697-2018-03763
Device Sequence Number1
Product Code MBH
UDI-Device Identifier07613327045802
UDI-Public07613327045802
Combination Product (y/n)N
PMA/PMN Number
K141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 03/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/30/2022
Device Catalogue Number5531G409
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received02/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age66 YR
Patient Weight72
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