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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRIATHLON KNEE SYSTEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRIATHLON KNEE SYSTEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number UNK_JR
Device Problem Loss of Osseointegration (2408)
Patient Problems Pain (1994); Injury (2348); Inadequate Osseointegration (2646)
Event Date 03/27/2020
Event Type  Injury  
Manufacturer Narrative
The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Device not returned.
 
Event Description
It¿s reported by the attorney, through the filing of a legal claim, that the patient underwent a right total knee arthroplasty on an unknown date in which he was implanted with a stryker triathlon knee system.It is further alleged that the patients right knee had to be revised on an unknown date due to mechanical loosening.
 
Event Description
It¿s reported by the attorney, through the filing of a legal claim, that the patient underwent a right total knee arthroplasty on an unknown date in which he was implanted with a stryker triathlon knee system.It is further alleged that the patients right knee had to be revised on an unknown date due to mechanical loosening.
 
Manufacturer Narrative
Reported event: an event regarding loosening involving an unknown triathlon knee was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided medical records by a clinical consultant indicated: no imaging studies are available for review and no examination of the explanted components is noted.There was no clinical improvement post-revision to competitive products, and no intraoperative or imaging studies diagnosis of either loosening or "failed" primary total knee components are noted.There is no evidence the persistent, chronic, compensable pain in the right knee is related to the primary total knee arthroplasty components, and apparently has persisted even after revision to completive products.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.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including device details, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
 
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Brand Name
UNKNOWN TRIATHLON KNEE SYSTEM
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
anna ryan
raheen business park
limerick, FL NA
EI   NA
9546280700
MDR Report Key9996348
MDR Text Key188850116
Report Number0002249697-2020-00795
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK_JR
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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) Hospitalization; Required Intervention;
Patient Age57 YR
Patient SexMale
Patient Weight79 KG
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