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 Codes	Degraded (1153); Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	01/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: suspected stem loosening (no loosening detected by orthopedic surgeon's imaging, but slight loosening identified by radiologist's interpretation) led to removal of the exeter stem.Discoloration was observed on the removed stem, prompting a request for investigation; however, the stem was discarded by the hospital.No complications or adverse events occurred during this procedure itself.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Reported event: an event regarding loosening and other (discoloration) involving an exeter stem was reported.The event of loosening was not confirmed; the event of discoloration was confirmed based on the provided photo.Method & results: -device evaluation and results: visual inspection: the reported device was not returned however a photograph was provided for review.The photograph shows an explanted exeter stem with blood on it.Dark brown/ black discoloration was noticed on the device surface.The identification of the discoloration cannot be determined.-clinician review: no medical records were received for review with a clinical consultant.-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.Conclusion: it was reported that the patient was revised due to suspected stem loosening.It's reported that no loosening detected by orthopedic surgeon's imaging, but slight loosening identified by radiologist's interpretation.Discoloration was observed on the removed stem.The reported device was not returned however a photograph was provided for review.The photograph shows an explanted exeter stem with blood on it.Dark brown/ black discoloration was noticed on the device surface.The identification of the discoloration cannot be determined.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the revision 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 devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24298569
• Report Number: 0002249697-2026-00082
• Device Sequence Number: 13103951
• Product Code: JDI
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K240418
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2026

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 Catalogue Number: 0580-1-440
• Device Lot Number: G8756336
• Was Device Available for Evaluation?: No
• 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: 01/14/2026
• Supplement Date Received by Manufacturer: 05/30/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2024
• 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; Hospitalization; Other
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 143 LB
• Patient Race: Asian