MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM BEAD PA SZE4 BP; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5526-B-400
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	10/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding malposition involving a triathlon baseplate was reported.The event was confirmed via clinician review of provided medical records.Method & results: product evaluation and results: material analysis, visual, functional, and dimensional inspections could not be performed as the device remains implanted.Clinician review: a review of the provided medical information by a clinical consultant indicated: "over a 10 year period there was substantial polyethylene wear that led to revision surgery device or procedure related adverse event: polyethylene wear leading to instability and revision surgery.The tibial component was placed in significant varus at the time of the primary surgery.Wear was evident with thinning of the polyethylene medially.In addition there was posterior translation of the femur on the tibia, the competency of the pcl could not be determined from the notes.Root cause and confirmation: a root cause cannot be determined without additional records.The revision surgery can be confirmed.Polyethylene wear can be confirmed.The root cause was likely varus malposition of the tibial component and perhaps pcl injury." product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to instability and fracture/wear of the triathlon insert.A review of the provided medical records by a clinical consultant confirmed joint instability and indicated that "the tibial component was placed in significant varus at the time of the primary surgery" and that this may have contributed to the event.Further information such as additional pre- and post-operative x-rays as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
"knee revision due to instability" was reported.Update 12-january-2023: per clinician review of provided medical records, "over a 10 year period there was substantial polyethylene wear that led to revision surgery device or procedure related adverse event: polyethylene wear leading to instability and revision surgery.The tibial component was placed in significant varus at the time of the primary surgery.".
Event or Problem Description
"knee revision due to instability" was reported.Update 12-january-2023: per clinician review of provided medical records, "over a 10 year period there was substantial polyethylene wear that led to revision surgery device or procedure related adverse event: polyethylene wear leading to instability and revision surgery.The tibial component was placed in significant varus at the time of the primary surgery.".
Additional Manufacturer Narrative
Reported event: an event regarding malposition involving a triathlon baseplate was reported.The event was confirmed via clinician review of provided medical records.Method & results: product evaluation and results: material analysis, visual, functional, and dimensional inspections could not be performed as the device remains implanted.Clinician review: a review of the provided medical information by a clinical consultant indicated: "over a 10 year period there was substantial polyethylene wear that led to revision surgery device or procedure related adverse event: polyethylene wear leading to instability and revision surgery.The tibial component was placed in significant varus at the time of the primary surgery.Wear was evident with thinning of the polyethylene medially.In addition there was posterior translation of the femur on the tibia, the competency of the pcl could not be determined from the notes.Root cause and confirmation: a root cause cannot be determined without additional records.The revision surgery can be confirmed.Polyethylene wear can be confirmed.The root cause was likely varus malposition of the tibial component and perhaps pcl injury." product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to instability and fracture/wear of the triathlon insert.A review of the provided medical records by a clinical consultant confirmed joint instability and indicated that "the tibial component was placed in significant varus at the time of the primary surgery" and that this may have contributed to the event.Further information such as additional pre- and post-operative x-rays as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON PRIM BEAD PA SZE4 BP
• Common Device Name: 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-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16292918
• Report Number: 0002249697-2023-00125
• Device Sequence Number: 6406435
• Product Code: MBH
• UDI-Device Identifier: 07613327041354
• UDI-Public: 07613327041354
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2023

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
• Operator of Device: Health Professional
• Device Model Number: 5526-B-400
• Device Catalogue Number: 5526B400
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/12/2023
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 02/03/2023
• Supplement Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown
• Patient Weight: 99 KG