MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	0580-1-443
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	10/11/2020
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
The following was reported: hip revision surgery due to patient's exeter stem 44 n3 being broken at neck level.
Event or Problem Description
The following was reported: hip revision surgery due to patient's exeter stem 44 n3 being broken at neck level.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture 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 a clinical consultant.Product history review: review of the device history records indicate the 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: the event could not be confirmed as insufficient information was provided.Further information such as device return, pre- and post-operative x-rays, primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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
The following was reported: hip revision surgery, due to patient's exeter stem 44 n3, being broken at neck level.
Additional Manufacturer Narrative
Reported event: an event, regarding crack/fracture involving a exeter stem was reported.The event was confirmed, via evaluation of the provided medical records.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: a review of the provided medical records, by a clinical consultant indicated.I can confirm, that the patient had the primary hip replacement, since i was able to review the operation report.I can also confirm, with secondary evidence that the patient had a revision of the left total hip arthroplasty, since i was able to review a radiology report, which stated there was an "interval revision of the left sided total hip arthroplasty.No x-ray documentation was provided.And no revision operation report was provided.Root cause analysis: the root cause of this event cannot be determined, with certainty.Causes of fracture of a prosthetic femoral neck are multifactorial including surgical technique, especially with a cemented implant regarding the cement mantle, patient factors including bmi and activity level.This patient apparently was quite active and had a bmi of over 34.Also to be considered, are 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: the event was confirmed.Via review of the provided medical records.Which indicated, "i can confirm, that the patient had the primary hip replacement, since i was able to review the operation report.I can also confirm, with secondary evidence that the patient had a revision of the left total hip arthroplasty, since i was able to review a radiology report.Which stated, there was an "interval revision of the left sided total hip arthroplasty".No x-ray documentation was provided.And no revision operation report was provided.Root cause analysis: the root cause of this event cannot be determined, with certainty.Causes of fracture of a prosthetic femoral neck are multifactorial including surgical technique.Especially, with a cemented implant regarding the cement mantle, patient factors including bmi and activity level.This patient apparently, was quite active and had a bmi of over 34.Also to be considered, are 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.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a exeter stem was reported.The event was confirmed via evaluation of the provided medical records.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: a review of the provided medical records by a clinical consultant indicated: i can confirm that the patient had the primary hip replacement since i was able to review the operation report.Originally, i was able to confirm with secondary evidence that the patient had a revision of the left total hip arthroplasty since i was able to review a radiology report which stated there was an "interval revision of the left sided total hip arthroplasty." now, with the additional documents supplied for the addendum i can confirm that the patient underwent revision of the left total hip arthroplasty since i was able to see x-ray with the revision implant in place.Root cause analysis: the root cause of this event cannot be determined with certainty.Causes of fracture of a prosthetic femoral neck are multifactorial including surgical technique, especially with a cemented implant regarding the cement mantle, patient factors including bmi and activity level.This patient apparently was quite active and had a bmi of over 34.Also to be considered are implant factors.The additional information does not change the root cause analysis.-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: the event was confirmed via review of the provided medical records which indicated, " i can confirm that the patient had the primary hip replacement since i was able to review the operation report.Originally, i was able to confirm with secondary evidence that the patient had a revision of the left total hip arthroplasty since i was able to review a radiology report which stated there was an "interval revision of the left sided total hip arthroplasty." now, with the additional documents supplied for the addendum i can confirm that the patient underwent revision of the left total hip arthroplasty since i was able to see x-ray with the revision implant in place.Root cause analysis: the root cause of this event cannot be determined with certainty.Causes of fracture of a prosthetic femoral neck are multifactorial including surgical technique, especially with a cemented implant regarding the cement mantle, patient factors including bmi and activity level.This patient apparently was quite active and had a bmi of over 34.Also to be considered are 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 3
• 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: 15798863
• Report Number: 0002249697-2022-01633
• Device Sequence Number: 19646394
• Product Code: JDI
• UDI-Device Identifier: 04546540153326
• UDI-Public: 04546540153326
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/25/2025
• 2 Devices were Involved in the Event: 1 2

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: 02/28/2023
• Device Model Number: 0580-1-443
• Device Catalogue Number: 0580-1-443
• Device Lot Number: G7279115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/19/2022
• Supplement Date Received by Manufacturer: 03/30/2023; 03/21/2024; 05/29/2025
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 04/24/2023; 04/11/2024; 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2018
• 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: 53 YR
• Patient Sex: Male