MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40(TM). FEM. STEM 37.5; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number	0580-3-321
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	09/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: the date of the initial surgery, surgical procedure, and implant inserted are unknown.On (b)(6) 2017, stem replacement surgery was performed at another hospital, and an exeterlong [0580-3-321] was implanted in the patient.On (b)(6) 2025, the patient was transferred to our hospital from another institution due to bone-fracture around femoral stem.Radiography confirmed a stem fracture in the femoral shaft and a fracture of the exeterlong implant approximately 2-3 cm from its tip.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture & periprosthetic fracture involving an exeter stem was reported.The event was confirmed via material analysis and clinician review of the provided medical records.Method & results: -product evaluation and results: a material analysis has been performed.The report concluded: 'review of the exeter stem, catalogue # 0580-3-422, lot code g7011718 confirmed fracture through the distal tip.Characterisation using stereo microscopy and scanning electron microscopy confirmed fracture to have propagated in fatigue.Due to the extensive mechanical damage on both fracture surfaces, nothing could be learned of the mode of final fracture.No manufacturing or material related defects were observed on the device surfaces examined.' clinician review: a review of the provided medical records by a clinical consultant indicated: 'a review of the provided medical records by a clinical consultant indicated: 'confirmation of event: i can confirm that the patient had a cemented long stem exeter implant with a lateral plate since i was able to view x-rays with the implant in place.I can also confirm that the patient developed a periprosthetic fracture with fracture of the femoral stem since i was able to view an x-ray with that situation.I can also confirm that the patient underwent a proximal femoral replacement with a constrained liner since i was also able to view an x-ray with the implant in place root cause analysis: the root cause of this event cannot be determined with certainty.Patient obviously had a failed hip arthroplasty which was treated with a cemented long stem implant and a lateral plate.The patient subsequently developed a periprosthetic fracture with fracture of the femoral stem.The patient may have had trauma but no information was given regarding the history.Surgical technique can contribute to the choice of implants, length of implant and method of fixation.The implant being in varus could contribute.Patient factors including lifestyle, activity level and bmi can also play a role.With the information provided i would not assign any causality to the implant itself.However, having said that the implant should be retained and submitted to stryker engineers for analysis to see if they can find the etiology of the stress fracture.' -product history review: review of the product history records indicate the reported device was manufactured with no reported relevant discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that '"the date of the initial surgery, surgical procedure, and implant inserted are unknown.On (b)(6) 2017, stem replacement surgery was performed at another hospital, and an exeterlong [0580-3-321] was implanted in the patient.On (b)(6) 2025, the patient was transferred to our hospital from another institution due to bone-fracture around femoral stem.Radiography confirmed a stem fracture in the femoral shaft and a fracture of the exeterlong implant approximately 2-3 cm from its tip.' a material analysis has been performed.The report concluded: 'review of the exeter stem, catalogue # 0580-3-422, lot code g7011718 confirmed fracture through the distal tip.Characterisation using stereo microscopy and scanning electron microscopy confirmed fracture to have propagated in fatigue.Due to the extensive mechanical damage on both fracture surfaces, nothing could be learned of the mode of final fracture.No manufacturing or material related defects were observed on the device surfaces examined.' a review of medical records with a clinical consultant indicated 'i can confirm that the patient had a cemented long stem exeter implant with a lateral plate since i was able to view x-rays with the implant in place.I can also confirm that the patient developed a periprosthetic fracture with fracture of the femoral stem since i was able to view an x-ray with that situation.I can also confirm that the patient underwent a proximal femoral replacement with a constrained liner since i was also able to view an x-ray with the implant in place root cause analysis: the root cause of this event cannot be determined with certainty.Patient obviously had a failed hip arthroplasty which was treated with a cemented long stem implant and a lateral plate.The patient subsequently developed a periprosthetic fracture with fracture of the femoral stem.The patient may have had trauma but no information was given regarding the history.Surgical technique can contribute to the choice of implants, length of implant and method of fixation.The implant being in varus could contribute.Patient factors including lifestyle, activity level and bmi can also play a role.With the information provided i would not assign any causality to the implant itself.However, having said that the implant should be retained and submitted to stryker engineers for analysis to see if they can find the etiology of the stress fracture.' no further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: EXETER V40(TM). FEM. STEM 37.5
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23097691
• Report Number: 0002249697-2025-01002
• Device Sequence Number: 8686202
• Product Code: JDG
• UDI-Device Identifier: 07613327123753
• UDI-Public: 07613327123753
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K240418
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2026

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: 08/31/2022
• Device Catalogue Number: 0580-3-321
• Device Lot Number: G7011718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/11/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2017
• 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: Required Intervention; Hospitalization
• Patient Age: 86 YR
• Patient Sex: Female