MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40(TM). FEM. STEM 44MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	0580-3-422
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Cardiac Arrest (1762); Embolism/Embolus (4438)
Date of Event	01/30/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Revision tha was performed on (b)(6) 2025 to replace the implant devices (competitor products) with new ones (stryker's products) because of the neck fracture of the competitor stem.The cup was replaced successfully, and the surgeon began to replace the stem as a next step.However, during stem replacement, the patient's electrocardiogram suddenly showed abnormal waveforms and her condition worsened.Although it was not confirmed properly, the anesthesiologist who participated in the operation stated, "it's a pulmonary embolism" during a lifesaving procedure of the sudden change in the patient's condition, so there is a possibility that the patient went into cardiac arrest due to a pulmonary embolism.As the patient went into cardiac arrest, the surgery discontinued, and the patient managed to regain consciousness on the same day through 30 minutes of cardiac massage and ecmo.The patient's final outcome after regaining consciousness is unknown.It was reported that the patient had no abnormalities such as primary disease at the time of surgery other than stem neck fracture.
Event or Problem Description
Revision tha was performed on (b)(6) 2025 to replace the implant devices (competitor products) with new ones (stryker's products) because of the neck fracture of the competitor stem.The cup was replaced successfully, and the surgeon began to replace the stem as a next step.However, during stem replacement, the patient's electrocardiogram suddenly showed abnormal waveforms and her condition worsened.Although it was not confirmed properly, the anesthesiologist who participated in the operation stated "it's a pulmonary embolism" during a lifesaving procedure of the sudden change in the patient's condition, so there is a possibility that the patient went into cardiac arrest due to a pulmonary embolism.As the patient went into cardiac arrest, the surgery discontinued, and the patient managed to regain consciousness on the same day through 30 minutes of cardiac massage and ecmo.The patient's final outcome after regaining consciousness is unknown.It was reported that the patient had no abnormalities such as primary disease at the time of surgery other than stem neck fracture.Update: patient died on (b)(6) 2025 due to a pulmonary embolus.
Additional Manufacturer Narrative
Corrected data: device details (cat#, gtin, product code, common device name).An event regarding patient factors (pulmonary embolism) involving a exeter stem was reported.The event was not confirmed.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: no medical records were received for review with 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 during the surgery, after the cup placement was completed and the stem on the femoral side was being re-replaced (the sales comment was, "the surgical field did not look clear, so this is just speculation, but we think it was when we were removing the soft tissue"), the patient's electrocardiogram suddenly showed abnormal waveforms and her condition suddenly worsened.The exact cause could not be determined as insufficient information was provided.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: EXETER V40(TM). FEM. STEM 44MM
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21490697
• Report Number: 0002249697-2025-00249
• Device Sequence Number: 15556987
• Product Code: JDI
• UDI-Device Identifier: 04546540153418
• UDI-Public: 04546540153418
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K011623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2025

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 Catalogue Number: 0580-3-422
• Device Lot Number: G8530397
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 02/28/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2024
• 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; Death
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian