MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TI DUR REG FLUTED STEM 13X80MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	6478-6-615
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	04/08/2022
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.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.Device not returned to the manufacturer.
Event or Problem Description
Surgeon reported that a revision surgery is required to a patient with an implanted gmrs stem, now identified being broken.
Event or Problem Description
Surgeon reported that a revision surgery is required to a patient with an implanted gmrs stem, now identified being broken.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a duracon stem was reported.The event was confirmed via clinician review of provided medical records.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: "this patient had a distal femoral replacement performed in 2010.Approximately 12 years later patient sustained a fracture of the proximal stem extension of the femoral component.I can confirm that the fracture occurred since i was able to see x-rays documenting it.As to the root cause of this event, i cannot determine this with certainty.Causes of failure and fracture of the stem extensions of prostheses are multifactorial.These most often occur when one portion of the stem is well fixed and the other is not.In this case i only have x-rays of poor quality and only x-rays with fracture.No previous x-rays are provided.The original operation report is not provided.If the procedure was done for a tumor, recurrence of the tumor could contribute.I am not able to see any cement fixation for the stem.I would also say that the stem is relatively short, anchoring a very bulky and heavy implant.Contributing factors to failure are the patient's bmi and activity level and age.With this type of an implant, with the event occurring 12 years after implantation, i would not believe that the fracture is due to any defect in the implant." -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 of the duracon stem.The event was confirmed through a review of the provided x-ray images by a clinical consultant, which indicated the following: "this patient had a distal femoral replacement performed in 2010.Approximately 12 years later patient sustained a fracture of the proximal stem extension of the femoral component.I can confirm that the fracture occurred since i was able to see x-rays documenting it.As to the root cause of this event, i cannot determine this with certainty.Causes of failure and fracture of the stem extensions of prostheses are multifactorial.These most often occur when one portion of the stem is well fixed and the other is not.In this case i only have x-rays of poor quality and only x-rays with fracture.No previous x-rays are provided.The original operation report is not provided.If the procedure was done for a tumor, recurrence of the tumor could contribute.I am not able to see any cement fixation for the stem.I would also say that the stem is relatively short, anchoring a very bulky and heavy implant.Contributing factors to failure are the patient's bmi and activity level and age.With this type of an implant, with the event occurring 12 years after implantation, i would not believe that the fracture is due to any defect in the implant." 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.

• Brand Name: TI DUR REG FLUTED STEM 13X80MM
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14321669
• Report Number: 0002249697-2022-00656
• Device Sequence Number: 5198289
• Product Code: JWH
• UDI-Device Identifier: 07613327044881
• UDI-Public: 07613327044881
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• PMA/510(K) Number: K973164
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2022

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: 11/30/2010
• Device Model Number: 6478-6-615
• Device Catalogue Number: 64786615
• Device Lot Number: TRN116D2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2022
• Supplement Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 10/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2005
• 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: Other
• Patient Sex: Unknown