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 Code	Fracture (1260)
Health Effect - Clinical Codes	Unspecified Infection (1930); Ambulation or Postural Difficulties (2544)
Date of Event	08/06/2024
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
Broken exeter stem.Revision surgery required.Booked for (b)(6) 2024.Additional information provided:the first stage revision surgery for this went ahead as planned yesterday (b)(6).Here is some more information i have been able to establish.The original surgery was performed about 8 years ago.A sinus developed in the femoral canal leading to a chronic infection.Broken distal stem was well fixed in canal.The rest of stem was loose & pulled out easily.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving an exeter stem was reported.The event was confirmed via clinician review of the provided medical records and evaluation of the returned device.Method & results: product evaluation and results: the image depicted shows the exeter v40 stem with fracture location highlighted.The fracture occurred through the distal tip of the stem.On visual examination, the fracture was observed approximately 35 mm from the distal tip.Stereo microscope imaging shows the fracture surface associated with the distal end of the stem.Shows the fracture surface associated with the proximal end of the stem.Shows explantation damage which was observed on all sides of the stem.Nothing could be learned of the cause of fracture due to post fracture abrasion and explantation damage.Due to the extensive mechanical damage on both fracture surfaces, nothing could be learned of the mode of fracture.No manufacturing or material related defects were observed on the device surfaces examined.Clinician review: a review of the provided medical information by a clinical consultant indicated: "confirmation of event: i can confirm that the patient had a hybrid of left total hip arthroplasty at some point in the past and i can confirm the fracture of the stem since i was able to review an x-ray with the implant and fracture.I cannot confirm the operative findings since i have no office notes, operation note or post revision x-ray.Root cause analysis: the root cause of this event cannot be determined with certainty.The root causes of a fractured stem in the face of infection are multifactorial.Regarding the fractured stem, this occurs when the distal portion of the stem is relatively well fixed and the proximal portion is relatively loose causing a stress fracture at the junction of the loose and well fixed stem.Infection can loosen the proximal portion of the implant.Other contributing factors include the patient's lifestyle, activity level and bmi as well as implant factors.The causes of periprosthetic infection several years after the initial surgery most likely are due to seeding of the joint from a remote area which has a collection of bacteria." 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 is planned to be revised due to fracture of the stem.The image depicted shows the exeter v40 stem with fracture location highlighted.The fracture occurred through the distal tip of the stem.On visual examination, the fracture was observed approximately 35 mm from the distal tip.Stereo microscope imaging shows the fracture surface associated with the distal end of the stem.Shows the fracture surface associated with the proximal end of the stem.Shows explantation damage which was observed on all sides of the stem.Nothing could be learned of the cause of fracture due to post fracture abrasion and explantation damage.Due to the extensive mechanical damage on both fracture surfaces, nothing could be learned of the mode of fracture.No manufacturing or material related defects were observed on the device surfaces examined.A review of the provided medical information by a clinical consultant indicated: "confirmation of event: i can confirm that the patient had a hybrid of left total hip arthroplasty at some point in the past and i can confirm the fracture of the stem since i was able to review an x-ray with the implant and fracture.I cannot confirm the operative findings since i have no office notes, operation note or post revision x-ray.Root cause analysis: the root cause of this event cannot be determined with certainty.The root causes of a fractured stem in the face of infection are multifactorial.Regarding the fractured stem, this occurs when the distal portion of the stem is relatively well fixed and the proximal portion is relatively loose causing a stress fracture at the junction of the loose and well fixed stem.Infection can loosen the proximal portion of the implant.Other contributing factors include the patient's lifestyle, activity level and bmi as well as implant factors.The causes of periprosthetic infection several years after the initial surgery most likely are due to seeding of the joint from a remote area which has a collection of bacteria." 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.
Event or Problem Description
Broken exeter stem.Revision surgery required.Booked for (b)(6) 2024.Additional information provided: the first stage revision surgery for this went ahead as planned yesterday (b)(6) here is some more information i have been able to establish.The original surgery was performed about 8 years ago.A sinus developed in the femoral canal leading to a chronic infection.Broken distal stem was well fixed in canal.The rest of stem was loose & pulled out easily.

• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20181561
• Report Number: 0002249697-2024-01232
• Device Sequence Number: 15519031
• Product Code: JDI
• UDI-Device Identifier: 04546540153296
• UDI-Public: 04546540153296
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K240418
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2025

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: 07/31/2017
• Device Catalogue Number: 0580-1-440
• Device Lot Number: G3281390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2012
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 108 KG