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

Catalog Number	0580-1-440
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	05/12/2025
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.
Event or Problem Description
Failed exeter stem from 2017 was revised (b)(6) 2025.Failed at an unusual location about halfway down where the stem snapped in half.
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: the reported device was not returned however photographs were provided for review.The photographs show a recently explanted exeter stem with a metal head assembled.The stem is fractured.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: clinician review: a review of medical records with a clinical consultant indicated "i have reviewed the documentation provided.Event description: failed exeter stem from 2017.Was revised 12/05/2025.Failed at an unusual location about halfway down where the stem snapped in half.The ap x-ray of a right tha shows a cemented exeter stem in a centralized position th stem has a transverse fracture at the midpoint of the stem.There is some lucency at the superior lateral bone interface of questionable importance.Fracture of a cemented exeter stem is confirmed.The root cause of this mechanical complication is not able to be determined from the information provided.Should further documentation becomes available i would be happy to further this investigation." -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 'failed exeter stem from 2017.Was revised 12/05/2025.Failed at an unusual location about halfway down where the stem snapped in half.' the reported device was not returned however photographs were provided for review.The photographs show a recently explanted exeter stem with a metal head assembled.The stem is fractured.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.A review of medical records with a clinical consultant indicated "i have reviewed the documentation provided.Event description: failed exeter stem from 2017.Was revised 12/05/2025.Failed at an unusual location about halfway down where the stem snapped in half.The ap x-ray of a right tha shows a cemented exeter stem in a centralized position th stem has a transverse fracture at the midpoint of the stem.There is some lucency at the superior lateral bone interface of questionable importance.Fracture of a cemented exeter stem is confirmed.The root cause of this mechanical complication is not able to be determined from the information provided.Should further documentation becomes available i would be happy to further this investigation." 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.
Event or Problem Description
No new information.

• Brand Name: EXETER V40 STEM 44MM NO 0
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: sanjana talathi ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22139531
• Report Number: 0002249697-2025-00586
• Device Sequence Number: 8149973
• Product Code: LPH
• UDI-Device Identifier: 04546540153296
• UDI-Public: 04546540153296
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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: 10/31/2021
• Device Catalogue Number: 0580-1-440
• Device Lot Number: G6135657
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2016
• 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: 82 YR
• Patient Sex: Male