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

Catalog Number	0580-1-044
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	03/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Postoperatively, the stem was broke off.The first surgery in this case was performed on (b)(6) 2014 and the first revision surgery was performed on (b)(6) 2018.The reason for the revision was probably stem loosening but cannot be identified.The product in question is a stem inserted into the patient at the revision surgery.
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving an exeter stem was reported.The event was confirmed via material analysis of the returned device.Method & results: product evaluation and results: visual inspection of the returned device indicated in mar report "the image 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 60 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.Image show explantation damage which was observed on the distal portion of the stem." 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 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 60 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.Image show explantation damage which was observed on the distal portion of the stem." 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.

• Brand Name: EXETER V40(TM). SHORT FEMORAL
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21688599
• Report Number: 0002249697-2025-00326
• Device Sequence Number: 9234500
• Product Code: LPH
• UDI-Device Identifier: 04546540509048
• UDI-Public: 04546540509048
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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: 08/31/2022
• Device Catalogue Number: 0580-1-044
• Device Lot Number: G7152308
• 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: 03/03/2025
• Supplement Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2017
• 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: Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female