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 Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	02/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
The following was reported: on the (b)(6) 2025, revision of broken exeter stem.No specific traumatic cause noted for the broken stem.
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: visual inspection was performed as part of the material analysis report (mar).This inspection indicated 'the exeter stem and femoral head were returned for investigation.Visual examination confirmed fracture through the neck of the stem.' a material analysis has been performed.The report concluded: 'review of the exeter stem, catalogue # 0580-1-440, lot code g6091653 and femoral head, unknown catalogue number and lot code confirmed a fracture through the neck of the stem.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 the provided medical records by a clinical consultant indicated: 'two of the x-rays show a cemented exeter stem with a complete fracture with angulation and displacement at the trunnion body junction.The third x-ray shows a cemented exeter stem in anatomic position with multiple cerclage cables.A cemented exeter stem with a complete fracture with angulation and displacement at the trunnion body junction is confirmed.The root cause for this mechanical complication cannot be determined from the documentation provided.Should further documentation become available, i would be happy to further this investigation.' -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 '"on (b)(6) 2025 dr revised a broken exeter stem.No specific traumatic cause noted for the broken stem.The stem was retained and decontaminated and they would like to looked at for analysis.".' visual inspection was performed as part of the material analysis report.This inspection indicated 'the exeter stem and femoral head were returned for investigation.Visual examination confirmed fracture through the neck of the stem.' a material analysis has been performed.The report concluded: 'review of the exeter stem, catalogue # 0580-1-440, lot code g6091653 and femoral head, unknown catalogue number and lot code confirmed a fracture through the neck of the stem.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 'a cemented exeter stem with a complete fracture with angulation and displacement at the trunnion body junction is confirmed.The root cause for this mechanical complication cannot be determined from the documentation provided.' should further documentation become available, i would be happy to further this investigation.' 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.
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: 22890124
• Report Number: 0002249697-2025-00914
• Device Sequence Number: 4849574
• 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
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

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: 02/28/2022
• Device Catalogue Number: 0580-1-440
• Device Lot Number: G6091653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/31/2025
• Supplement Date Received by Manufacturer: 11/30/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2017
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown