MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 33MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	0580-1-330
Medical Device Problem Codes	Fracture (1260); Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	09/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: exeter stem broken in situ.
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There has been similar event(s) for the lot referenced.If additional information is received, it will be provided 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.Loosening was identified during clinician review of the provided medical records.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: clinician review: a review of medical records with a clinical consultant indicated 'the x-ray reveals a right sided cemented exeter stem.There are subtle lucencies about the proximal portion of the stem suggestive of loss of fixation.There is a transverse fracture of in the mid portion of the stem with mild displacement and angulation.The root cause for this mechanical failure cannot be determined from the limited documentation provided.' -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 01 other similar event for the lot referenced.Conclusions: it was reported that 'exeter stem broken in situ.' a review of medical records with a clinical consultant indicated 'the x-ray reveals a right sided cemented exeter stem.There are subtle lucencies about the proximal portion of the stem suggestive of loss of fixation.There is a transverse fracture of in the mid portion of the stem with mild displacement and angulation.The root cause for this mechanical failure cannot be determined from the limited documentation provided.' 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 33MM
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23131613
• Report Number: 0002249697-2025-01018
• Device Sequence Number: 21311271
• Product Code: JDI
• UDI-Device Identifier: 04546540153227
• UDI-Public: 04546540153227
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K240418
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2026

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: 05/31/2020
• Device Catalogue Number: 0580-1-330
• Device Lot Number: G5694211
• 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: 09/05/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/18/2015
• 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: Required Intervention; Other; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Female