MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI PRESS-FIT STEM 18MM X 100MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5565-S-018
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Ambulation or Postural Difficulties (2544)
Date of Event	02/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Stem disassociated from the right femoral component.Required revision surgery.No allegations against the insert or augment.
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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.Device not returned.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation and crack/fracture involving a triathlon stem was reported.The event was confirmed via clinician review of the provided medical records and evaluation of photographs of the device.Method & results: -product evaluation and results: the reported device was not returned however photographs were provided for review.Visual inspection of the provided intraoperative photographs indicated that the stem is not attached to the femoral component.It appears that the threaded end of the stem is damaged and/or fractured.-clinician review: a review of the provided medical information by a clinical consultant indicated: "this inquiry reports the revision of a revision total knee replacement about 9 years after implantation due to disassociation of the femoral stem from the housing.I can confirm that the disassociation or fracture took place since i was able to see the xrays.However, i cannot confirm that the revision took place since i have no documentation such as an operation report and post revision xrays.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of stem disassociation or fracture are multifactorial including surgical technique issues, patient activity and bmi factors and implant factors.It is possible that the distal portion of the construct may have had some micromovement.When coupled with a well-fixed stem, fracture or disassociation could occur." -product history review: review of the device history records indicate the 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 disassociation of the stem from the femoral component.The reported device was not returned however photographs were provided for review.Visual inspection of the provided intraoperative photographs indicated that the stem is not attached to the femoral component.It appears that the threaded end of the stem is damaged and/or fractured.A review of the provided medical information by a clinical consultant indicated: "this inquiry reports the revision of a revision total knee replacement about 9 years after implantation due to disassociation of the femoral stem from the housing.I can confirm that the disassociation or fracture took place since i was able to see the xrays.However, i cannot confirm that the revision took place since i have no documentation such as an operation report and post revision xrays.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of stem disassociation or fracture are multifactorial including surgical technique issues, patient activity and bmi factors and implant factors.It is possible that the distal portion of the construct may have had some micromovement.When coupled with a well-fixed stem, fracture or disassociation could occur." the exact cause of the event could not be determined from the information provided.Further information such as return of the devices, primary and revision operative reports 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.
Event or Problem Description
Stem disassociated from the right femoral component.Required revision surgery.No allegations against the insert or augment.

• Brand Name: TRI PRESS-FIT STEM 18MM X 100MM
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 13845064
• Report Number: 0002249697-2022-00420
• Device Sequence Number: 11925921
• Product Code: MBH
• UDI-Device Identifier: 07613327026818
• UDI-Public: 07613327026818
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 08/31/2022

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: 07/31/2017
• Device Model Number: 5565-S-018
• Device Catalogue Number: 5565-S-018
• Device Lot Number: M7L46E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 03/22/2022
• Supplement Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2012
• 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