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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE 4 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE 4 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Model Number 5531-G-409
Device Problem Insufficient Information (3190)
Patient Problems Aspiration/Inhalation (1725); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Swelling (2091); Ambulation Difficulties (2544)
Event Date 07/25/2013
Event Type  Injury  
Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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.Reportable other: the following devices were also listed in this report: simplex p half dose 1 pack; cat # 6188-1-001; lot # rdt041.Triathlon asymmetric x3 patella; cat # 5551-g-350; lot # 035w.Triathlon cr fem comp #4 r-cem; cat # 5510f402; lot # shphr.Triathlon prim tib baseplate - cemented; cat # 5520-b-400; lot # zcvt.Simplex p full dose 1 pack; cat # 6191-1-001; lot # rap059.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
 
Event Description
Information received includes a report dated (b)(6) 2013: "diagnosis: infected right knee.The knee is red and swollen.This was prepped and aspirated of 20 cc of bloody fluid.Also during the procedure she had a lateral release." patient was placed on antibiotics.
 
Event Description
Information received includes a report dated (b)(6) 2013: "diagnosis: infected right knee.The knee is red and swollen.This was prepped and aspirated of 20cc of bloody fluid.Also during the procedure she had a lateral release." patient was placed on antibiotics.
 
Manufacturer Narrative
Reported event: an event regarding patient factors is reported involving triathlon insert.The event of aspiration was confirmed based on medical review, but no device specific failure modes were identified or confirmed.Method & results: product evaluation and results- product inspection - material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted.Clinical review: a review of the provided medical records and/or x-rays by a clinical consultant stated that : ¿ the following adverse events were identified: revision due to patellar impingement and failure of fixation and subsequent quadriceps rupture with repair x2.The aspirations from the cross-referenced events were also confirmed.Hazards: none clearly related to implant conclusion of assessment: the revision surgery was confirmed as were the two quadriceps repairs.-product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the event was reported about patient factors is reported involving triathlon insert.The event of aspiration was confirmed based on medical review, but no device specific failure modes were identified or confirmed.A review of the provided medical records and/or x-rays by a clinical consultant stated that : ¿ the following adverse events were identified: revision due to patellar impingement and failure of fixation and subsequent quadriceps rupture with repair x2.The aspirations from the cross-referenced events were also confirmed.Hazards: none clearly related to implant conclusion of assessment: the revision surgery was confirmed as were the two quadriceps repairs.The exact cause of the event could not be determined because insufficient information was provided.Further information is needed to complete the investigation for determining its root cause.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
 
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Brand Name
X3 TRIATHLON CS INS SIZE 4 9MM
Type of Device
PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key10173122
MDR Text Key195716048
Report Number0002249697-2020-01234
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
Type of Report Initial,Followup
Report Date 09/09/2020
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 Date10/31/2016
Device Model Number5531-G-409
Device Catalogue Number5531G409
Device Lot NumberLCP991
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/02/2020
Initial Date FDA Received06/19/2020
Supplement Dates Manufacturer Received08/13/2020
Supplement Dates FDA Received09/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age74 YR
Patient Weight104
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