MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRESS-FIT STEM 20MM X 150MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5566-S-020
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	03/21/2022
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
It was reported that the patient's left knee was revised due to the ts stem breaking at the threaded junction of the femoral component.The femoral component and stem were revised.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a triathlon stem was reported.The event was confirmed through clinician review of the provided medical records.Method & results: product evaluation and results: visual inspection of the returned device indicated that it has fractured.Clinician review: a review of the provided medical records by a clinical consultant indicated: these inquiries report the failure of a primary total hip replacement due to femoral component fracture necessitating revision of all three components.It also reports the failure of the revision total knee replacement due to stem extension fracture.I can confirm that these events took place since i was able to review the xrays prior to revision and after revision when the stem failed.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of femoral implant fracture and stem extension fracture are multifactorial including surgical technique factors, patient factors including activity level, weight and bmi, and implant factors.The surgeon elected to cement a press fit stem and i cannot determine if that was a contributing factor as well.-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.Conclusion: an event regarding crack/fracture of the triathlon stem was reported.Visual inspection of the returned device indicated that it has fractured.A review of the provided medical records by a clinical consultant indicated: these inquiries report the failure of a primary total hip replacement due to femoral component fracture necessitating revision of all three components.It also reports the failure of the revision total knee replacement due to stem extension fracture.I can confirm that these events took place since i was able to review the xrays prior to revision and after revision when the stem failed.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of femoral implant fracture and stem extension fracture are multifactorial including surgical technique factors, patient factors including activity level, weight and bmi, and implant factors.The surgeon elected to cement a press fit stem and i cannot determine if that was a contributing factor as well.No further investigation for this event is possible at this time.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
It was reported that the patient's left knee was revised due to the ts stem breaking at the threaded junction of the femoral component.The femoral component and stem were revised.

• Brand Name: TRIATHLON PRESS-FIT STEM 20MM X 150MM
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14113880
• Report Number: 0002249697-2022-00515
• Device Sequence Number: 17455822
• Product Code: MBH
• UDI-Device Identifier: 07613327027709
• UDI-Public: 07613327027709
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K070095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2022

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 Expiration Date: 12/31/2022
• Device Model Number: 5566-S-020
• Device Catalogue Number: 5566-S-020
• Device Lot Number: 0061982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2022
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 138 KG