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	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	03/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device has been returned.Additional information will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
As reported by the rep: "exeter stem broke without trauma.It was discovered on a post op x-ray after hip surgery on other side.Patient complained of pain but non operated hip was worse.Now they did revision surgery on the side with the broken stem and will send back the parts of the implant for investigation." update: it was noted that loosening of the stem may have led to the stem fracture.The rimfit cup was replaced with a dual mobility cup for better outcome.There was nothing wrong with the cup, it was well cemented and in place.
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: the reported device was in-vivo for a period of 10 years.¿the implants are designed to function as intended for at least ten years post-implantation under normal use conditions¿.Given the duration of implantation, interaction of various factors and longevity of the implant dependent on patient weight and level of activity, the device shall not require a material analysis as it has exceeded the expected life of the device." clinician review: a review of medical records with a clinical consultant indicated "i can confirm that the patient underwent a primary cemented exeter total hip arthroplasty on the left side if conventional orientation was utilized.I can confirm that a fracture of the femoral stem was present.I can do so since i was able to view radiographs with the implant and the fracture in place.While the event description mentions that revision surgery was carried out, i cannot confirm that because i have no supportive documentation other than that notation.Root cause analysis: the root cause of this event cannot be determined with certainty.The root causes of late femoral, stem fracture of an exeter femoral implant are multifactorial.These include surgical technique, especially in the way that the cement is inserted, and the implant secured.In this case, the cement mantel was grade c/d.If the implant was relatively fixed distally, the proximal portion of the implant could toggle and a stress fracture can occur.Other factors, including patient¿s lifestyle, activity level, and bmi can contribute as well as implant factors." 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.The reported device was in-vivo for a period of 10 years.¿the implants are designed to function as intended for at least ten years post-implantation under normal use conditions¿.Given the duration of implantation, interaction of various factors and longevity of the implant dependent on patient weight and level of activity, the device shall not require a material analysis as it has exceeded the expected life of the device." a review of medical records with a clinical consultant indicated "i can confirm that the patient underwent a primary cemented exeter total hip arthroplasty on the left side if conventional orientation was utilized.I can confirm that a fracture of the femoral stem was present.I can do so since i was able to view radiographs with the implant and the fracture in place.While the event description mentions that revision surgery was carried out, i cannot confirm that because i have no supportive documentation other than that notation.Root cause analysis: the root cause of this event cannot be determined with certainty.The root causes of late femoral, stem fracture of an exeter femoral implant are multifactorial.These include surgical technique, especially in the way that the cement is inserted, and the implant secured.In this case, the cement mantel was grade c/d.If the implant was relatively fixed distally, the proximal portion of the implant could toggle and a stress fracture can occur.Other factors, including patient¿s lifestyle, activity level, and bmi can contribute as well as implant factors." 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: 21787402
• Report Number: 0002249697-2025-00384
• Device Sequence Number: 21035557
• Product Code: JDI
• UDI-Device Identifier: 04546540153296
• UDI-Public: 04546540153296
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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: 11/30/2019
• Device Catalogue Number: 0580-1-440
• Device Lot Number: G5553202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/10/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 04/07/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2014
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 71 KG