MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	0580-1-440
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
Broken exeter stem at neck/shoulder junction.
Event or Problem Description
Broken exeter stem at neck/shoulder junction.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving an exeter stem was reported.The event was confirmed via clinician review of provided medical records.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned stem indicated it had fractured at the neck.Plastic surface deformation consistent with micro-motion at the stem-cement interface was observed on the surfaces of the stem.This abrasion is indicative of cyclic stress-strain ultimately leading to fatigue fracture of the stem.-clinician review: a review of the provided medical information by a clinical consultant indicated: "summary: this product inquiry concerns a 58-year-old male patient who underwent a primary right total hip arthroplasty with a cementless cup and a cemented exeter stem.The date of implant was (b)(6) 2018.The patient sustained a fracture of the exeter implant at the junction between the shoulder and the base of the femoral neck.Patient underwent explantation on (b)(6) 2024.Confirmation of event: i can confirm that the patient had a primary total hip arthroplasty as described above since i was able to see an x-ray with the implant in place with the fractured stem.I cannot confirm the explantation as i have no documentation except for a date supplied with the product inquiry.Root cause analysis: the root cause of this event cannot be determined with certainty with the information given.The causes of fracture of a cemented femoral stem are multifactorial including surgical technique, especially in the cementing of the implant (in this case it appears to be well cemented), patient factors including the patient's bmi and activity level, and 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: it was reported that the patient was revised due to fracture of the exeter stem.The event was confirmed by a review of the provided x-ray image by a clinical consultant: "confirmation of event: i can confirm that the patient had a primary total hip arthroplasty as described above since i was able to see an x-ray with the implant in place with the fractured stem.I cannot confirm the explantation as i have no documentation except for a date supplied with the product inquiry.Root cause analysis: the root cause of this event cannot be determined with certainty with the information given.The causes of fracture of a cemented femoral stem are multifactorial including surgical technique, especially in the cementing of the implant (in this case it appears to be well cemented), patient factors including the patient's bmi and activity level, and implant factors." 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, 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: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19174605
• Report Number: 0002249697-2024-00642
• Device Sequence Number: 12621437
• Product Code: LPH
• UDI-Device Identifier: 04546540153296
• UDI-Public: 04546540153296
• Combination Product (Y/N): N
• Initial Reporter State: VI
• Initial Reporter Country: AS
• PMA/510(K) Number: K011623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2024

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: 10/15/2022
• Device Catalogue Number: 0580-1-440
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/28/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2017
• 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: 58 YR
• Patient Sex: Male