MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 35.5MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 0580-1-351

Device Problem Loss of Osseointegration (2408)

Patient Problem Inadequate Osseointegration (2646)

Event Date 10/26/2022

Event Type  Injury  

Event Description

It was reported by the sales rep that the surgeon notify on a possible removal case due to loosening.

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not returned.

Manufacturer Narrative

An event regarding loosening, osteolysis, subsidence, and probable pathological fracture involving an exeter stem was reported.The event was confirmed via clinician review of the provided medical records.Method & results: device 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: conclusion of assessment: this patient underwent a hybrid right total hip arthroplasty and approximately 3 1/2 years later developed osteolysis, subsidence, and loosening with probable pathological fracture of the greater trochanter.This necessitated revision surgery.No information was given about the revision.I can confirm that the patient had the primary total hip arthroplasty with the above radiographic findings since i was able to review an x-ray, although no date or demographics were present on the x-ray.I cannot determine the root cause of this event with certainty.The causes of osteolysis, loosening, pathological fracture and polyethylene wear are multifactorial including surgical technique factors, patient activity levels and bmi, as well as 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.Conclusion: a review of the provided medical information by a clinical consultant indicated: this patient underwent a hybrid right total hip arthroplasty and approximately 3 1/2 years later developed osteolysis, subsidence, and loosening with probable pathological fracture of the greater trochanter.This necessitated revision surgery.No information was given about the revision.I can confirm that the patient had the primary total hip arthroplasty with the above radiographic findings since i was able to review an x-ray, although no date or demographics were present on the x-ray.I cannot determine the root cause of this event with certainty.The causes of osteolysis, loosening, pathological fracture and polyethylene wear are multifactorial including surgical technique factors, patient activity levels and bmi, as well as 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.

Event Description

It was reported by the sales rep that the surgeon notify on a possible removal case due to loosening.Update as per medical review: "preoperative x-rays reveal a cementless acetabular cup with adequate fixation and possible polyethylene wear.The femoral component showed significant osteolysis with probable pathological fracture of the greater trochanter with very little cement fixation in a distal pedestal beneath the femoral implant.".

• Brand Name: EXETER V40 STEM 35.5MM
• Type of Device: 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: 15812795
• MDR Text Key: 303795525
• Report Number: 0002249697-2022-01655
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 04546540153234
• UDI-Public: 04546540153234
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K173499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/10/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 0580-1-351
• Device Catalogue Number: 0580-1-351
• Device Lot Number: G7550994
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2022
• Initial Date FDA Received: 11/17/2022
• Supplement Dates Manufacturer Received: 01/17/2023
• Supplement Dates FDA Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male