MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	0580-1-440
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	05/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported: ""i implanted this hip back in 2017.Leg gave way yesterday whilst mowing the lawn.Stem fracture at neck ¿ very odd!".
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.
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: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review with a clinical consultant indicated "i can confirm that the patient underwent a primary right total hip arthroplasty on (b)(6) 2017 since i was able to review the operation report.I can also confirm that the patient sustained a periprosthetic fracture since i was able to see an x-ray with the diagnosis.The root cause of this event cannot be determined with certainty.The causes of periprosthetic fracture are multifactorial including surgical technique, cementing technique, cement integrity as well as positioning and initial stability.Patient factors including lifestyle, activity level and bmi also must be considered as well as implant factors.Trauma could also be a factor if for example a fall occurred.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 "i can confirm that the patient underwent a primary right total hip arthroplasty on (b)(6) 2017 since i was able to review the operation report.I can also confirm that the patient sustained a periprosthetic fracture since i was able to see an x-ray with the diagnosis.The root cause of this event cannot be determined with certainty.The causes of periprosthetic fracture are multifactorial including surgical technique, cementing technique, cement integrity as well as positioning and initial stability.Patient factors including lifestyle, activity level and bmi also must be considered as well as implant factors.Trauma could also be a factor if for example a fall occurred.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
No new information.

• Brand Name: EXETER V40 STEM 44MM NO 0
• 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: 22250632
• Report Number: 0002249697-2025-00624
• Device Sequence Number: 8031683
• Product Code: JDI
• UDI-Device Identifier: 04546540153296
• UDI-Public: 04546540153296
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2025

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: 09/30/2021
• Device Catalogue Number: 0580-1-440
• Device Lot Number: G6091655
• 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: 05/25/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown