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

Catalog Number	0580-1-044
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	01/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: "broken metal stem in 20-year-old hip prosthesis".
Event or Problem Description
*update based on medical review: "it shows a different view of the fractured stem.Considerable black material is present on the stem and possibly within the trunnion.There is rather significant polyethylene war (wear) with fracture of the metallic marker wire."[.]" confirmation of event "[.]" i was able to review x-rays with the implant in place with polyethylene wear and fracture of the marker wire.I can also confirm that the patient developed a fracture of the stem with which he was revised at the base of the exeter neck and stem."[.]"".
Additional Manufacturer Narrative
An event regarding crack/fracture involving an exeter stem was reported.The event was confirmed via evaluation of the returned device and medical review.Method & results: -product evaluation and results: visual inspection of the returned device indicated the stem's tapered neck had fractured off and was stuck in the head.Material analysis was not performed as the implant was from a 20-year-old hip prosthesis.-clinician review: a review of the provided medical records by a clinical consultant indicated: "confirmation of event: i can confirm that the patient had a cemented total hip replacement since i was able to review x-rays with the implant in place with polyethylene wear and fracture of the marker wire.I can also confirm that the patient developed a fracture of the stem with which he was revised at the base of the exeter neck and stem.Root cause analysis: the root cause of these events cannot be determined with certainty.Causes of acetabular polyethylene wear with fracture of the marker wire are multifactorial including surgical technique, patient lifestyle, activity level and bmi as well as implant factors.The causes of femoral neck/stem fracture are also multifactorial including surgical technique in the way that the implant is cemented in place, the patient¿s lifestyle and activity level, bmi and implant factors." -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 "broken metal stem in 20-year-old hip prosthesis".Visual inspection of the returned device indicated the stem's tapered neck had fractured off and was stuck in the head.A review of the provided medical records by a clinical consultant indicated that " the root cause of these events cannot be determined with certainty.Causes of acetabular polyethylene wear with fracture of the marker wire are multifactorial including surgical technique, patient lifestyle, activity level and bmi as well as implant factors.The causes of femoral neck/stem fracture are also multifactorial including surgical technique in the way that the implant is cemented in place, the patient¿s lifestyle and activity level, bmi and implant factors." 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, 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: 24442524
• Report Number: 0002249697-2026-00127
• Device Sequence Number: 10364024
• Product Code: JDI
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K240418
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2026

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 Expiration Date: 03/31/2011
• Device Catalogue Number: 0580-1-044
• Device Lot Number: G1315127
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2006
• 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: 77 YR
• Patient Sex: Male
• Patient Weight: 191 LB
• Patient Race: White