MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 50MM NO 1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	0580-1-501
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Periprosthetic fracture (4902)
Date of Event	01/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
This pi is for the jr implants.It was reported that the patient's right hip was revised due to proximal femoral fracture rep confirmed fracture was proximal to axsos 3 cortex screws and that no screws were damaged.All implants were removed.Stryker acetabular components and competitor femoral components were implanted.Rep confirmed that no further information will be released by the hospital or surgeon.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
The following devices were also listed in this report: exeter x3 rimfit id40 od60 e; cat# 73094060 ; lot# lnb239 d-m 2.0mm beaded cable set vit; cat# 6704-0-520 ; lot# 29167551 x 5 d-m 2.0mm beaded cable set vit; cat# 6704-0-520 ; lot# 20158151 d-m 2.0mm beaded cable set vit; cat# 6704-0-520 ;lot# 29169251 d-m 2.0mm beaded cable set vit; cat# 6704-0-520 ;lot# 29706551 d-m 2.0mm beaded cable set vit; cat# 6704-0-520 ;lot# 90570201 trochanteric grip plate with 2; cat# 6704-3-083 ;lot# g8448031 it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: an event regarding periprosthetic fracture involving an 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 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 periprosthetic fracture.The exact cause of the event could not be determined because insufficient information was provided.Further information such as 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 50MM 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: anna ryan ; raheen business park; limerick, NJ NA ; EI NA ; +353 2018315000
• MDR Report Key: 24390636
• Report Number: 0002249697-2026-00107
• Device Sequence Number: 10567872
• Product Code: LPH
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• 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: 0580-1-501
• Device Lot Number: G8429802
• 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: 01/23/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2023
• 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: 62 YR
• Patient Sex: Male