MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TI DUR REG FLUTED STEM 19X80MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	64786645
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	09/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.The following devices were also listed in this report: cat#: 64811131; mrh knee fem l rgt; lot#: eh3eh.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.H3 other text: not returned to the manufacturer.
Event or Problem Description
Fracture of the femoral shaft from the mrh femur.Additional information: the stem with mrh femur was implanted properly in 2016, femur cemented, stem cementless.The patient complained of pain in 2023, so a revision was necessary.During this op.It was discovered that the femoral stem was fractured at the threaded attachment from the femoral component.
Event or Problem Description
Fracture of the femoral shaft from the mrh femur.Additional information: the stem with mrh femur was implanted properly in 2016, femur cemented, stem cementless.The patient complained of pain in 2023, so a revision was necessary.During this op.It was discovered that the femoral stem was fractured at the threaded attachment from the femoral component.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation and crack/fracture involving an duracon stem was reported.The event of disassociation was confirmed.Method & results: product evaluation and results: the duracon stem was returned for evaluation.Severe mechanical damage observed consistent with explantation.Clinician review: a review with a clinical consultant indicated "preoperative x-rays prior to index right knee surgery demonstrated windblown deformities of both knees with severe valgus deformity on the right an advanced varus deformity on the left.Postoperative x-rays show a modular rotating hinge tka in anatomic alignment.The femoral component is cemented.The femoral stem is pressfit.Prevision x-rays show that the femoral component has collapsed into valgus.The femoral stem position remains unchanged.This indicative of stem failure, fracture of the stem is not directly seen on x-ray review either than the malalignment of the stem and femoral component.It is confirmed that there was a failure of a mrh femoral stem with loss of fixation of the femur.The root cause of the stem failure cannot be determined from the documentation provided." 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: a review with a clinical consultant indicated "preoperative x-rays prior to index right knee surgery demonstrated windblown deformities of both knees with severe valgus deformity on the right an advanced varus deformity on the left.Postoperative x-rays show a modular rotating hinge tka in anatomic alignment.The femoral component is cemented.The femoral stem is pressfit.Prevision x-rays show that the femoral component has collapsed into valgus.The femoral stem position remains unchanged.This indicative of stem failure, fracture of the stem is not directly seen on x-ray review either than the malalignment of the stem and femoral component.It is confirmed that there was a failure of a mrh femoral stem with loss of fixation of the femur.The root cause of the stem failure cannot be determined from the documentation provided." no further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TI DUR REG FLUTED STEM 19X80MM
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17841655
• Report Number: 0002249697-2023-01099
• Device Sequence Number: 15247068
• Product Code: JWH
• UDI-Device Identifier: 07613327044942
• UDI-Public: 07613327044942
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K973164
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2024

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: 11/30/2020
• Device Catalogue Number: 64786645
• Device Lot Number: 0040057
• 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: 09/04/2023
• Supplement Date Received by Manufacturer: 12/22/2023
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2015
• 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: 79 YR
• Patient Sex: Male
• Patient Weight: 97 KG