MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 35.5MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	0580-1-351
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	07/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported "exeter broke off in a patient who had tha performed on (b)(6) 2022 and was reoperated on today.".
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving an exeter stem was reported.The event was confirmed.Method & results: -product evaluation and results: visual inspection: visual inspection was performed as part of the material analysis report (mar).This inspection indicated 'visual examination confirmed fracture through the mid-stem region.' a material analysis has been performed.The report concluded: 'review of the exeter stem, catalogue # 0580-1-351, lot code g8279280 confirmed fracture through the mid-stem region.Characterisation using stereo microscopy and scanning electron microscopy confirmed fracture to have propagated in fatigue with final fracture in overload.No manufacturing or material related defects were observed on the device surfaces examined.' clinician review: a review of medical records with a clinical consultant indicated 'i can confirm that the patient underwent a right total hip arthroplasty and subsequently sustained a fracture of the femoral stem since i was able to see an x-ray with the stem fracture.I cannot confirm that the patient did have the revision since i have no documentation for that procedure except that it was mentioned in the product inquiry summary.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of stem fracture following a cemented femoral implant are multifactorial.These include surgical technique, especially the choice of implant and the way the implant is positioned and cemented.Patient factors including lifestyle, activity level and bmi are relevant as well as implant factors.In this case, the implant appeared to be well fixed distally with possibly less than adequate fixation approximately which can result in a 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 'exeter broke off in a patient who had tha performed on (b)(6) 2022, and was reoperated on today.' a material analysis has been performed.The report concluded: 'review of the exeter stem, catalogue # 0580-1-351, lot code g8279280 confirmed fracture through the mid-stem region.Characterisation using stereo microscopy and scanning electron microscopy confirmed fracture to have propagated in fatigue with final fracture in overload.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 underwent a right total hip arthroplasty and subsequently sustained a fracture of the femoral stem since i was able to see an x-ray with the stem fracture.I cannot confirm that the patient did have the revision since i have no documentation for that procedure except that it was mentioned in the product inquiry summary.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of stem fracture following a cemented femoral implant are multifactorial.These include surgical technique, especially the choice of implant and the way the implant is positioned and cemented.Patient factors including lifestyle, activity level and bmi are relevant as well as implant factors.In this case, the implant appeared to be well fixed distally with possibly less than adequate fixation approximately which can result in a stress fracture.' no further investigation for this event is possible at this time.If device/additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: EXETER V40 STEM 35.5MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 22833638
• Report Number: 0002249697-2025-00885
• Device Sequence Number: 9522838
• Product Code: JDI
• UDI-Device Identifier: 04546540153234
• UDI-Public: 04546540153234
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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: 09/30/2026
• Device Catalogue Number: 0580-1-351
• Device Lot Number: G8279280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/14/2021
• 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: 41 YR
• Patient Sex: Male
• Patient Weight: 68 KG