MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	0580-1-441
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	02/06/2025
Type of Reportable Event	Serious Injury
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
Trauma revision case of 9 year old exeter stem.It was found during the revision the stem had fractured at the head/neck junction.Surgeon believes it was due to metal fatigue.
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 medical review and inspection of the returned device.Method & results: product evaluation and results: the reported device was in-vivo for a period of almost 10 years.As per diovv document ¿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 the provided medical records by a clinical consultant stated the following comment: "i can confirm that the patient underwent a hybrid left total hip arthroplasty since i was able to see an x-ray with the implant and the head neck disassociation/fracture of the trunnion.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of fracture at the head, neck, junction or trunnion or multifactorial.Contributing factors include surgical technique, which, in this case i would question, whether or not there may have been chronic impingement because of the horizontal nature of the position of the acetabular component.Also contributing could be the patient lifestyle, activity level and bmi.In the product inquiry summary, it includes the term ¿trauma revision case.¿if this was trauma related, then i would not necessarily assign any causality to the implant.If not, the implant would have to be examined by stryker engineers to determine if any defects were present.If it were due to impingement, then again, i would not assign any causality to the implant itself." 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 almost 10 years.As per diovv document ¿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 the provided medical records by a clinical consultant stated the following comment: "i can confirm that the patient underwent a hybrid left total hip arthroplasty since i was able to see an x-ray with the implant and the head neck disassociation/fracture of the trunnion.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of fracture at the head, neck, junction or trunnion or multifactorial.Contributing factors include surgical technique, which, in this case i would question, whether or not there may have been chronic impingement because of the horizontal nature of the position of the acetabular component.Also contributing could be the patient lifestyle, activity level and bmi.In the product inquiry summary, it includes the term ¿trauma revision case.¿if this was trauma related, then i would not necessarily assign any causality to the implant.If not, the implant would have to be examined by stryker engineers to determine if any defects were present.If it were due to impingement, then again, i would not assign any causality to the implant itself." 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 STEM 44MM NO 1
• 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: 21514213
• Report Number: 0002249697-2025-00268
• Device Sequence Number: 4501201
• Product Code: LPH
• UDI-Device Identifier: 04546540153302
• UDI-Public: 04546540153302
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2025

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 Expiration Date: 11/30/2019
• Device Catalogue Number: 0580-1-441
• Device Lot Number: G5557457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2014
• 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: 61 YR
• Patient Sex: Male