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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
Model Number 5532-G-609
Device Problem Insufficient Information (3190)
Patient Problems Calcium Deposits/Calcification (1758); Injury (2348)
Event Date 11/24/2015
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.The following devices were also listed in this report: triathlon asymmetric x3 patella; cat # 5551-g-350; lot # 7kw6.Triathlon prim tib baseplate - cemented; cat# 5520-b-600; lot # hjzld.Triathlon ps fem component, cemented; cat # 5515-f-602; lot # iaubd.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
 
Event Description
Based on the medical review the patient underwent right knee arthroplasty on (b)(6) 2013.Right knee x-rays documented abnormal calcification near the inferior pole of the patella.With persistent complaints it was decided to remove this calcification and this was performed on (b)(6) 2015.Arthrotomy was performed with removal of the bony ossicle and partial lateral release of the patella.
 
Event Description
Based on the medical review the patient underwent right knee arthroplasty on 28 march 2013.Right knee x-rays documented abnormal calcification near the inferior pole of the patella.With persistent complaints it was decided to remove this calcification and this was performed on 24 november 2015.Arthrotomy was performed with removal of the bony ossicle and partial lateral release of the patella.
 
Manufacturer Narrative
Reported event: an event regarding patient factors involving a triathlon insert was reported.The event was confirmed through clinician review of the provided medical records.Method & results: -product evaluation and results: not performed as no product was returned for evaluation.-clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: right knee x-rays documented an abnormal calcification near the inferior pole of the patella after persistent complaints.Arthrotomy was performed on 24 november 2015 to remove the bony ossicle and partial release of the patella.-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: a review of the provided medical records and x-rays by a clinical consultant indicated: on 09 april 2014 right knee pain developed anteriorly and laterally on activity the patient had a local corticosteroid injection for a diagnosis of lateral synovitis.Right knee x-rays documented an abnormal calcification near the inferior pole of the patella after persistent complaints.Arthrotomy was performed on 24 november 2015 to remove the bony ossicle and partial release of the patella.[.] no device-related factors are associated with any of the implanted devices.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
 
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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
MDR Report Key9997914
MDR Text Key189295012
Report Number0002249697-2020-00801
Device Sequence Number1
Product Code MBH
UDI-Device Identifier07613327050844
UDI-Public07613327050844
Combination Product (y/n)N
PMA/PMN Number
K141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 06/23/2020
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 Date10/31/2017
Device Model Number5532-G-609
Device Catalogue Number5532-G-609
Device Lot NumberMLPW1M
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/27/2020
Initial Date FDA Received04/24/2020
Supplement Dates Manufacturer Received05/27/2020
Supplement Dates FDA Received06/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age55 YR
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