MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40(TM). SHORT FEMORAL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	0580-1-044
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	12/02/2024
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
Exeter stem fractured inside patient requiring removal and replacement with another stem.The date of stem fractured inside patient is unknown and the mechanism of fracture is also unknown.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving an exeter stem was reported.The event was confirmed via inspection of the returned device.Method & results: -product evaluation and results: visual inspection of the returned device indicated in mar report.The image depicted shows the exeter v40 stem with fracture location highlighted.The fracture occurred through the distal portion of the stem.On visual examination, the fracture was observed approximately 35 mm from the distal tip.Stereo microscope imaging was performed on both the distal and proximal fracture surfaces, respectively.Based on macroscopic surface features observed, including beach marks, the approximate location of origin (o) and direction of propagation (p) were determined.Nothing could be learned of the final fracture location due to post fracture abrasion and explantation damage.The macroscopic surface features observed on the fracture surface indicate the component fracture propagated in fatigue.Figure shows explantation damage which was observed on the distal portion of the stem.Material analysis: review of the exeter stem, catalogue # 0580-1-044, lot code g3583367 confirmed a fracture through the distal tip of the stem.Characterisation using stereo microscopy and scanning electron microscopy confirmed fracture to have propagated in fatigue.Due to the extensive mechanical damage on both fracture surfaces, nothing could be learned of the mode of final fracture.No manufacturing or material related defects were observed on the device surfaces examined.-clinician review: no medical records were received for review with a clinical consultant.-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 the patient was revised due to fracture of the stem.Visual inspection of the returned device indicated in mar report.The image depicted 1 shows the exeter v40 stem with fracture location highlighted.The fracture occurred through the distal portion of the stem.On visual examination, the fracture was observed approximately 35 mm from the distal tip.Stereo microscope imaging was performed on both the distal and proximal fracture surfaces, respectively.Based on macroscopic surface features observed, including beach marks, the approximate location of origin (o) and direction of propagation (p) were determined.Nothing could be learned of the final fracture location due to post fracture abrasion and explantation damage.The macroscopic surface features observed on the fracture surface indicate the component fracture propagated in fatigue.Figure shows explantation damage which was observed on the distal portion of the stem.Material analysis: review of the exeter stem, catalogue # 0580-1-044, lot code g3583367 confirmed a fracture through the distal tip of the stem.Characterisation using stereo microscopy and scanning electron microscopy confirmed fracture to have propagated in fatigue.Due to the extensive mechanical damage on both fracture surfaces, nothing could be learned of the mode of final fracture.No manufacturing or material related defects were observed on the device surfaces examined.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
Exeter stem fractured inside patient requiring removal and replacement with another stem.The date of stem fractured inside patient is unknown and the mechanism of fracture is also unknown.

• Brand Name: EXETER V40(TM). SHORT FEMORAL
• 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: 20979367
• Report Number: 0002249697-2024-01769
• Device Sequence Number: 14441960
• Product Code: JDI
• UDI-Device Identifier: 04546540509048
• UDI-Public: 04546540509048
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2025

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: 01/31/2018
• Device Catalogue Number: 0580-1-044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 12/19/2024
• Supplement Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2013
• 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: 75 YR
• Patient Sex: Male