MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TI DUR REG FLUTED STEM11X155MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	64786685
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	10/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's left knee was revised due to the stem breaking at the junction with the femoral component of a hinged knee construct.Revising surgeon reported he feels the femoral side should have been a distal femoral replacement.The patient's mrs/ mrh knee components (except for the proximal tibial component and stem) were revised.Rep provided all information that was available from the hospital and surgeon.
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.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a duracon stem was reported.The event was confirmed via clinician review.Method & results: -product evaluation and results: the reported device was not returned however photographs were provided for review.Visual inspection of the provided photographs of the devices indicate that the devices have been recently explanted and are covered in blood/tissue and bone cement.A portion of the threaded junction of the femoral component appears to have fractured off.The stem is covered in blood, bone cement and tissue, the visible side of the stem appears unremarkable.No conclusive decision regarding the stem can be made from the photo.-clinician review: a review of medical records with a clinical consultant indicated "the ap and lateral x-rays show that hinged femoral component has fractured at its connection to the stem.Stem breaking at the junction with the femoral component of a hinged knee construct is confirmed.No documentation was available to confirm that a revision was completed.The root cause of the stem breakage cannot be determined from the limited documentation provided.Should additional information become available i would be happy to further this assessment." -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 fracture at the stem/femoral component interface.The reported device was not returned however photographs were provided for review.Visual inspection of the provided photographs of the devices indicate that the devices have been recently explanted and are covered in blood/tissue and bone cement.A portion of the threaded junction of the femoral component appears to have fractured off.The stem is covered in blood, bone cement and tissue, the visible side of the stem appears unremarkable.No conclusive decision regarding the stem can be made from the photo.A review of medical records with a clinical consultant indicated "the ap and lateral x-rays show that hinged femoral component has fractured at its connection to the stem.Stem breaking at the junction with the femoral component of a hinged knee construct is confirmed.No documentation was available to confirm that a revision was completed.The root cause of the stem breakage cannot be determined from the limited documentation provided.Should additional information become available i would be happy to further this assessment." 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
It was reported that the patient's left knee was revised due to the stem breaking at the junction with the femoral component of a hinged knee construct.Revising surgeon reported he feels the femoral side should have been a distal femoral replacement.The patient's mrs/ mrh knee components (except for the proximal tibial component and stem) were revised.Rep provided all information that was available from the hospital and surgeon.

• Brand Name: TI DUR REG FLUTED STEM11X155MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18158258
• Report Number: 0002249697-2023-01430
• Device Sequence Number: 7999012
• Product Code: JWH
• UDI-Device Identifier: 07613327044980
• UDI-Public: 07613327044980
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K973164
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2024

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 Expiration Date: 04/30/2025
• Device Catalogue Number: 64786685
• Device Lot Number: 0101038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2023
• Supplement Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2020
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 127 KG