MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #4L; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5517F401
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision of a left total knee.The revision today was performed secondary to pain and stiffness.In surgery it was discovered that the femur was not ingrown.The femur and insert were removed.It was decided to convert to a ps femur to allow for a better range of motion.The use of mako in the primary surgery was not thought to have contributed to this early failure.No further information available from the doctor or hospital.
Additional Manufacturer Narrative
An event regarding loosening involving a triathlon femoral component 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 remains implanted.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to pain and stiffness.The exact cause of the event could not be determined because insufficient information was provided.In surgery it was discovered that the femur was not ingrown.Further information such as pathology reports, 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 become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON P/A CR BEADED #4L
• 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: arunabha mukherjee ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20155567
• Report Number: 0002249697-2024-01217
• Device Sequence Number: 18241953
• Product Code: MBH
• UDI-Device Identifier: 07613327040937
• UDI-Public: 07613327040937
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K051380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/06/2024

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 Catalogue Number: 5517F401
• Device Lot Number: S67LU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2023
• 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 Age: 74 YR
• Patient Sex: Female