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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5532-G-409-E
Device Problems Device Damaged Prior to Use (2284); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/27/2023
Event Type  malfunction  
Manufacturer Narrative
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.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.H3 other text : device not returned to the manufacturer.
 
Event Description
When the iud was removed from the packaging during implantation, it had a loose locking wire.The surgeon had to take another implant, this one was not implanted.
 
Manufacturer Narrative
Reported event: an event regarding disassociation involving a triathlon insert was reported.The event was confirmed via the provided photograph of the device.Method & results: -product evaluation and results: the reported device was not returned; however, a photograph was provided for review.The photograph shows the insert in a plastic bag with labels.The labels partially obscure the view of the insert but it appears that the locking wire has completely disassociated from the poly insert.Nothing further can be observed from the photograph.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate 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 referenced.Conclusions: it was reported that the locking wire came loose from the triathlon insert during surgery.The reported device was not returned; however, a photograph was provided for review.The photograph shows the insert in a plastic bag with labels.The labels partially obscure the view of the insert but it appears that the locking wire has completely disassociated from the poly insert.Nothing further can be observed from the photograph.Further information such as return of the device is needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If device(s) and/or additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
 
Event Description
When the iud was removed from the packaging during implantation, it had a loose locking wire.The surgeon had to take another implant, this one was not implanted.
 
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Brand Name
TRIATHLON PS X3 TIBIAL INSERT
Type of Device
PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
sanjana talathi
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key17983375
MDR Text Key326233740
Report Number0002249697-2023-01238
Device Sequence Number1
Product Code MBH
UDI-Device Identifier07613327338355
UDI-Public07613327338355
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K172634
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5532-G-409-E
Device Lot NumberL91A6L
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/27/2023
Initial Date FDA Received10/23/2023
Supplement Dates Manufacturer Received12/07/2023
Supplement Dates FDA Received12/27/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/20/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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