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	Pain (1994)
Date of Event	11/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient presented at our emergency department on (b)(6) 2025.He had been experiencing exertion-dependent pain in his right hip for approximately three weeks following total hip replacement.He could not recall any trauma.An outpatient examination revealed a shaft fracture of the prosthesis.The patient was admitted to the orthopedic surgery department.
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 evaluation of the returned device.Method & results: -product evaluation and results: visual inspection: visual inspection & material analysis: review of the exeter stem, catalogue # 0580-1-044, lot code g8373911 confirmed fracture through the mid-stem region.Characterisation using stereo microscopy and scanning electron microscopy confirmed fracture to have propagated in fatigue.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: "confirmation of event: i can confirm that the patient underwent a cemented exeter femoral prosthesis implantation along with a screw type cementless cup with a ceramic head since i was able to review xrays with the implant in place.I cannot confirm the date because no information is given other than the implantation and explanation dates in the product inquiry.Similarly i can only confirm that the patient had a revision procedure since i was able to review x-rays with a revision implant in place but i cannot confirm the date or any other details.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of femoral prosthesis fracture are multifactorial including surgical technique factors and patient factors including activity level, lifestyle and bmi.In this case i believe this primary implant was used in a revision fashion and was inserted penetrating the femoral cortex.This can contribute to the event.With the information provided i would not necessarily assign any causality to the implant itself unless the implant was examined by stryker engineers and found to be defective.The distal cement was grade a and the proximal cement was grade b which could lead to a stress riser." -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 the patient was revised due to fracture of the exeter stem.A review of the provided medical records by a clinical consultant indicated: "confirmation of event: i can confirm that the patient underwent a cemented exeter femoral prosthesis implantation along with a screw type cementless cup with a ceramic head since i was able to review xrays with the implant in place.I cannot confirm the date because no information is given other than the implantation and explanation dates in the product inquiry.Similarly i can only confirm that the patient had a revision procedure since i was able to review x-rays with a revision implant in place but i cannot confirm the date or any other details.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of femoral prosthesis fracture are multifactorial including surgical technique factors and patient factors including activity level, lifestyle and bmi.In this case i believe this primary implant was used in a revision fashion and was inserted penetrating the femoral cortex.This can contribute to the event.With the information provided i would not necessarily assign any causality to the implant itself unless the implant was examined by stryker engineers and found to be defective.The distal cement was grade a and the proximal cement was grade b which could lead to a stress riser." visual inspection & material analysis: review of the exeter stem, catalogue # 0580-1-044, lot code g8373911 confirmed fracture through the mid-stem region.Characterisation using stereo microscopy and scanning electron microscopy confirmed fracture to have propagated in fatigue.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 becomes 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 23802373
• Report Number: 0002249697-2025-01471
• Device Sequence Number: 7686069
• Product Code: LPH
• UDI-Device Identifier: 04546540509048
• UDI-Public: 04546540509048
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2026

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 Catalogue Number: 0580-1-044
• Device Lot Number: G8373911
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 70 YR
• Patient Sex: Unknown
• Patient Weight: 80 KG
• Patient Race: White