MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM CEM FXD BPLT #1; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5520-B-100
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	02/13/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Right tka.Revision due to loosening of tibial component.
Event or Problem Description
Right tka.Revision due to loosening of tibial component.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a triathlon baseplate was reported.The event was confirmed by clinical consultant.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 information by a clinical consultant indicated: event description: right tka for oa.Revision due to loosening of tibial component.Implants involved: triathlon ps fem #1 right cemented, triathlon primary baseplate tibia-cemented #1.Materials reviewed: 02/13/2021: stryker pi report12/29/2020: x-ray ap/lat right knee.?weightbearing, mild djd and lateral chondrocalcinosis01/15/2021: x-ray right knee ap/lat.Primary triathlon cemented ps with primary cemented baseplate.Tibia in perhaps very slight varus but appears engaged with bone med and lat.02/13/2021: x-ray right knee ap/lat.Primary triathlon cemented ps with primary cemented baseplate.Tibia in varus with lift off laterally.03/15/2021: x-ray right knee ap/lat.Primary triathlon cemented ps with primary cemented baseplate.Tibia in marked varus with lift off laterally increased from 02/13/2021.Confirmation: failure of a triathlon cemented primary baseplate may be confirmed from the x-ray series.The revision cannot be confirmed without additional medical records/op notes/radiographs.Root cause: very early failure of a cemented tibial component approximately 6 weeks is highly unusual without some inciting event.Assessing a root cause is not possible without additional medical records and history and perhaps examination of the explant.-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: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report 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 devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not returned.

• Brand Name: TRIATHLON PRIM CEM FXD BPLT #1
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11668856
• Report Number: 0002249697-2021-00684
• Device Sequence Number: 11553422
• Product Code: MBH
• UDI-Device Identifier: 07613327041040
• UDI-Public: 07613327041040
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2021

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: 5520-B-100
• Device Catalogue Number: 5520B100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention