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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_TRIATHLON TIBIAL BASEPLATE; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_TRIATHLON TIBIAL BASEPLATE; 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 Injury (2348); Joint Laxity (4526)
Event Date 06/01/2020
Event Type  Injury  
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.
 
Event Description
Surgeon provided pictures of an explanted triathlon ps insert.On followup, the following were reported to r&d for advanced materials & processing: patient's knee was revised.Confirmed no infection.Severe varus deformity with varus thrust.Medial subluxation noted intra-operatively.On the lateral side, the cemented baseplate was lifting off.Liner became deformed as a result.It is unknown at the time of report what steps were taken to address the tibial baseplate.
 
Event Description
Surgeon provided pictures of an explanted triathlon ps insert.On followup, the following were reported to r&d for advanced materials & processing: patient's knee was revised.Confirmed no infection.Severe varus deformity with varus thrust.Medial subluxation noted intra-operatively.On the lateral side, the cemented baseplate was lifting off.Liner became deformed as a result.It is unknown at the time of report what steps were taken to address the tibial baseplate.
 
Manufacturer Narrative
Reported event: an event regarding loosening involving an unknown triathlon baseplate was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: "the undated and unlabeled ap knee x-rays (one left, the other unlabeled) presumably preoperative to the revision showed some possible loosening of the tibial component and indeterminate rotation of the femoral component.The undated right lateral x-ray (partial clipped image attached as well), showed that appeared to be well fixed and positioned implants with calcifications/ heterotopic bone in the capsule posteriorly and some over-growth anteriorly.Adverse event identified: knee instability with polyethylene damage (pitting, discoloration, delamination) leading to right knee revision surgery.Hazard: none clearly related to implant.Conclusion of assessment: the knee was revised due to ligamentous instability.The polyethylene damage was likely the result of the knee's instability.Obtaining the implant may provide insight into the mechanism of failure and confirm lack of inherent polyethylene defects." product history review: not performed as the device lot details were not provided.Complaint history review: not performed as the device lot details were not provided.Conclusions: clinician review on the provided medical records did not confirm the baseplate loosening.It is unknown at the time of report what steps were taken to address the tibial baseplate.The exact cause of the event could not be determined because insufficient information was provided.Further information such as device details and return of the device are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
 
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Brand Name
UNKNOWN_TRIATHLON TIBIAL BASEPLATE
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 Key10183796
MDR Text Key196074314
Report Number0002249697-2020-01255
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2020
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
Date Manufacturer Received09/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age65 YR
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